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Reserved Medical Devices

The following devices are devices that FDA believes meet the reserved criteria in section 206 of the Modernization Act and, therefore, would remain subject to premarket notification under new section 510(l) added to the act:

862.1065 Ammonia test system.  
862.1113 Bilirubin (total and unbound) in the neonate test system.  
862.1175 Cholesterol (total) test system.  
862.1310 Galactose test system.  
862.1410 Iron (non-heme) test system.  
862.1415 Iron-binding capacity test system.  
862.1450 Lactic acid test system.  
862.1495 Magnesium test system.  
862.1510 Nitrite (nonquantitative) test system.  
862.1580 Phosphorus (inorganic) test system.  
862.1660 Quality control material (assayed and unassayed). 1  
862.1675 Blood specimen collection device.  
862.1680 Testosterone test system.  
862.1705 Triglyceride test system.  
862.1730 Free tyrosine test system.  
862.1775 Uric acid test system.  
862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.  
862.3040 Alcohol test system.  
862.3050 Breath-alcohol test system.  
862.3110 Antimony test system.  
862.3120 Arsenic test system.  
862.3220 Carbon monoxide test system.  
862.3240 Cholinesterase test system.  
862.3280 Clinical toxicology control material. 1  
862.3600 Mercury test system.  
862.3750 Quinine test system.  
862.3850 Sulfonamide test system.  
864.3250 Specimen transport and storage container. 86  
864.7040 Adenosine triphosphate release assay.  
864.8950 Russell viper venom reagent.  
864.9050 Blood bank supplies.  
864.9125 Vacuum-assisted blood collection system. 2  
866.2390 Transport culture medium.  
866.2560 Microbial growth monitor.  
866.2850 Automated zone reader.  
866.2900 Microbiological specimen collection and transport device.  
866.3040 Aspergillusspp. serological reagents.  
866.3110 Campylobacter fetusserological reagents.  
866.3120 Chlamydia serological reagents.  
866.3235 Epstein-Barr virus serological reagents.  
866.3330 Influenza virus serological reagents.  
866.3370 Mycobacterium tuberculosisimmunofluorescent reagents.  
866.3400 Parainfluenza virus serological reagents.  
866.3480 Respiratory syncytial virus serological reagents.  
866.3870 Trypanosomaspp. serological reagents.  
868.1100 Arterial blood sampling kit.  
868.5240 Anesthesia breathing circuit.  
868.5540 Rigid laryngoscope.  
868.5770 Tracheal tube fixation device.  
868.6810 Tracheobronchial suction catheter. 81  
870.4500 Cardiovascular surgical instruments.  
872.3240 Dental bur. 90  
872.3520 OTC denture cleanser. 91  
872.3700 Dental mercury.  
872.3980 Endosseous dental implant accessories.  
872.4200 Dental handpiece and accessories.  
872.4535 Dental diamond instrument. 92  
872.4565 Dental hand instrument. 93  
872.4730 Dental injecting needle. 94  
872.5410 Orthodontic appliance and accessories. 95  
872.6250 Dental chair and accessories. 18  
872.6510 Oral irrigation unit.  
872.6640 Dental operative unit and accessories. 21  
872.6710 Boiling water sterilizer.  
872.6855 Manual toothbrush.  
874.4140 Ear, nose, and throat bur.  
874.4420 Ear, nose, and throat manual surgical instrument. 24  
876.1075 Gastroenterology-urology biopsy instrument. 26  
876.4680 Ureteral stone dislodger.  
878.4014 Nonresorbable gauze/sponge for external use.  
878.4200 Introduction/drainage catheter and accessories.  
878.4460 Surgeon's glove.  
878.4800 Manual surgical instrument for general use.  
878.5900 Nonpneumatic tourniquet.  
880.5090 Liquid bandage. 8  
880.5680 Pediatric position holder.  
880.6250 Patient examination glove.  
880.6375 Patient lubricant.  
880.6760 Protective restraint.  
880.6960 Irrigating syringe.  
882.1030 Ataxiagraph.  
882.1420 Electroencephalogram (EEG) signal spectrum analyzer.  
882.4060 Ventricular cannula. 9  
882.4190 Clip forming/cutting instrument.  
882.4525 Microsurgical instrument.  
882.4545 Shunt system implantation instrument. 10  
884.1730 Laparoscopic insufflator. 51  
884.2980 Telethermographic system.  
884.2982 Liquid crystal thermographic system.  
884.4520 Obstetric-gynecologic general manual instrument.  
884.5435 Unscented menstrual pad. 80  
886.4070 Powered corneal burr. 14  
886.4300 Intraocular lens guide. 15  
886.4350 Manual ophthalmic surgical instrument.  
886.4370 Keratome.  
890.3475 Limb orthosis.  
890.3850 Mechanical wheelchair.  
890.5710 Hot or cold disposable pack. 16  
892.1100 Scintillation (gamma) camera.  
892.1110 Positron camera.  

Footnotes:

1

Exemption is limited to unassayed material, except when used in conjunction with donor screening tests.

2

Exemption is limited to manual devices.

8

Exemption is limited to uses as a skin protectant.

9

Exemption is limited to surgical grade stainless steel.

10

The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory is exempt from the premarket notification procedures .

14

Exemption is limited to rust ring removal.

15

Exemption does not apply if used as folders and injectors for soft or foldable IOL's.

16

Exemption does not apply when indicated for infants.

18

Only chairs without operative unit device are 510(k) exempt. Dental chair with operative unit, product code KLC, requires 510(k) clearance. Dental chair without operative unit, product code NRU, is exempt from 510(k).

21

Only the accessories tray to the unit is 510(k) exempt. Dental operative unit, product code EIA, requires 510(k) clearance. Oral cavity evacuator, product code EHZ , is exempt from 510(k). Saliva ejector mouthpiece, product code DYN , is exempt from 510(k). Suction operatory unit, product code EBR, is exempt from 510(k). Operative dental unit accessories, product code NRD, is exempt from 510(k).

24

510(k) exempt only if the device is made of the same materials that were used in the device before May 28, 1976.

26

Only biopsy forceps cover and the non­electric biopsy forceps are 510(k) exempt.

51

Only tubing and tubing/filter kits which include accessory instruments which are not used to effect intra­abdominal access, Verres needles etc.; and single­use tubing kits used for only intra­abdominal insufflation (pneumoperitoneum) are 510(k) exempt.

80

510(k) exempt only when the device is made of common celluosic and synthetic material with an established safety profile. Exemption does not include the intralabial pads and reusable menstrual pads.

81

Device is not exempt from the design control requirements section of the GMP.

86

This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

90

Reprocessed diamond-coated bur, product code NME, requires 510(k) clearance.

91

Prescription denture cleanser, product code NUX, requires 510(k) clearance. An Rx denture cleanser is an effervescent tablet for the removal of micro-organisms from removable dentures and retainers. Over the counter denture cleanser, product code EFT, is 510(k) exempt.

92

Reprocessed diamond dental instrument, product code NLD, requires 510(k) clearance. Diamond dental instrument, product code DZP, is 510(k) exempt.

93

If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9.
The following three product codes associated with this regulation require 510(k) clearance. There are 59 product codes associated with this regulation that are exempt from 510(k).
Dental lapping tool kit, product code NYG, requires 510(k) clearance. Parallelometer, product code EGI, requires 510(k) clearance. (Dental) irrigating syringe, product code EIB, requires 510(k) clearance.

94

Reprocessed dental needle, product code NMW, requires 510(k) clearance. Dental needle, product code DZM, is exempt from 510(k).

95

Reprocessed orthodontic metal bracket, product code NQS, requires 510(k) clearance. Product codes ECI, DYO, ECM, EJF, ECN, DYJ, ECO, DZD, DZC, are exempt from 510(k).
 
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