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U.S. Department of Health and Human Services

Product Classification

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Device immunoassay, insulin-like growth factor binding protein-1
Regulation Description Urinary pH (nonquantitative) test system.
Definition The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions.The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.
Physical State The kit contains multiple test packs, each containing one sterile polyester swab for specimen collection, one tube of Specimen Extraction Solution, and one dipstick in a sealed aluminum foil pouch.
Technical Method The test is based on immunochromatography.
Target Area Cervicovaginal specimens are collected and used on the device.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeOAM
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 862.1550
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Third Party Review Not Third Party Eligible
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