Recognized Consensus Standards

Recognition List Number: 016 Publication Date: 11/03/2006 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-4: CLSI / NCCLS GP14-A 1996, Labeling of Home-Use In Vitro Testing Products; Approved Guideline. (InVitro Diagnostics)

Date of Standard: 1996. 

Addresses of Standards Organizations:

  Clinical Laboratory Standards Institute (CLSI)

  950 West Valley Road

  Suite 2500

  Wayne, PA 19087

  National Committee for Clinical Laboratory Standards (NCCLS)

  950 West Valley Road

  Suite 2500

  Wayne, PA 19087

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF DEVICE EVALUATION (ODE)

(2)	OFFICE OF COMPLIANCE (OC)

Devices Affected:

Home Use IVD's

Processes Affected:

Manufacturing/Devices Evaluation (510(k), PMA, PDP, IDE)

Type of Standard:

 National, Horizontal

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§862.1115	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Class 1	JJB
Regulation Number	Device Name	Device Class	Product Code
§862.1155	Agglutination Method, Human Chorionic Gonadotropin	Class 2	JHJ
§862.1155	Kit, Test, Pregnancy, Hcg, Over The Counter	Class 2	LCX
§862.1155	Visual, Pregnancy Hcg, Prescription Use	Class 2	JHI
Regulation Number	Device Name	Device Class	Product Code
§862.1170	Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride	Class 2	CHK
Regulation Number	Device Name	Device Class	Product Code
§862.1175	Enzymatic Esterase--Oxidase, Cholesterol	Class 1	CHH
Regulation Number	Device Name	Device Class	Product Code
§862.1340	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Class 2	JIL
Regulation Number	Device Name	Device Class	Product Code
§862.1345	Glucose Oxidase, Glucose	Class 2	CGA
§862.1345	Hexokinase, Glucose	Class 2	CFR
Regulation Number	Device Name	Device Class	Product Code
§862.1435	Nitroprusside, Ketones (Urinary, Non-Quant.)	Class 1	JIN
Regulation Number	Device Name	Device Class	Product Code
§862.1485	Radioimmunoassay, Luteinizing Hormone	Class 1	CEP
Regulation Number	Device Name	Device Class	Product Code
§862.1510	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Class 1	JMT
Regulation Number	Device Name	Device Class	Product Code
§862.1550	Dye-Indicator, Ph (Urinary, Non-Quant.)	Class 1	CEN
Regulation Number	Device Name	Device Class	Product Code
§862.1645	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Class 1	JIR
Regulation Number	Device Name	Device Class	Product Code
§862.1785	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Class 1	CDM
Regulation Number	Device Name	Device Class	Product Code
§862.2300	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Class 1	JJQ
Regulation Number	Device Name	Device Class	Product Code
§864.6550	Blood, Occult, Colorimetric, In Urine	Class 2	JIO
§864.6550	Reagent, Occult Blood	Class 2	KHE
Regulation Number	Device Name	Device Class	Product Code
§864.7470	Assay, Glycosylated Hemoglobin	Class 2	LCP
Regulation Number	Device Name	Device Class	Product Code
§866.2900	Device, Specimen Collection	Class 1	LIO

Relevant Guidance:

Review Criteria for Assessment of Over-The-Counter Human Chorionic Gonadotropin (HCG) In Vitro Diagnostic Devices. Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians Office Laboratories, and Home Use. Points to Consider for Approval of Home Drugs of Abuse Test Kits. Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices

FDA Technical Contact:

  Arleen Pinkos

  FDA/CDRH/OIVD

  10903 New Hampshire Avenue Building 66, Room 5618

  Silver Spring MD 20993

  301/796-6152

  Email: arleen.pinkos@fda.hhs.gov