Cleared Traditional

K920401 - IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST

K920401 is an FDA 510(k) clearance for IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST, manufactured by General Biometrics, Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K920401 · General Biometrics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
204d
Days
Class 2
Risk

K920401 is an FDA 510(k) clearance for the IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on August 20, 1992 after a review of 204 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all General Biometrics, Inc. devices

FDA 510(k) Submission Details - K920401

510(k) Number K920401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1992
Decision Date August 20, 1992
Days to Decision 204 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 104d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MID Device Classification - Class 2, Special Controls

Product Code MID System, Test, Anticardiolipin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - MID System, Test, Anticardiolipin Immunological

All 72
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K920401.
QUANTA LITE ACA SCREEN
K923320 · Inova Diagnostics, Inc. · Sep 1992
DIASTAT TOTAL ANTI-CARDIOLIPIN KIT
K923886 · Shield Diagnostics, Ltd. · Sep 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST
K920400 · General Biometrics, Inc. · Aug 1992
DIASTAT ANTI-CARDIOLIPIN KIT
K921265 · Shield Diagnostics, Ltd. · Aug 1992
SYNELISA CARDIOLIPIN ANTIBODIES
K921250 · Elias U.S.A., Inc. · Jun 1992
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
K911661 · Immuno Concepts, Inc. · Dec 1991