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U.S. Department of Health and Human Services

Product Classification

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Device immunoassay for detection of amniotic fluid protein(s).
Regulation Description Urinary pH (nonquantitative) test system.
Definition The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.
Physical State cassette, dip stick or dipstrip
Technical Method Immunoassay
Target Area : for testing cervicovaginal fluid specimens
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeNQM
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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