Cleared Traditional

K921250 - SYNELISA CARDIOLIPIN ANTIBODIES

K921250 is an FDA 510(k) clearance for SYNELISA CARDIOLIPIN ANTIBODIES, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K921250 · Elias U.S.A., Inc. · Immunology device
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Jun 1992
Decision
80d
Days
Class 2
Risk

K921250 is an FDA 510(k) clearance for the SYNELISA CARDIOLIPIN ANTIBODIES. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on June 4, 1992 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elias U.S.A., Inc. devices

FDA 510(k) Submission Details - K921250

510(k) Number K921250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date June 04, 1992
Days to Decision 80 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
25d faster than avg
Panel avg: 105d · This submission: 80d
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 76
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K921250.
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST
K920400 · General Biometrics, Inc. · Aug 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
K920401 · General Biometrics, Inc. · Aug 1992
DIASTAT ANTI-CARDIOLIPIN KIT
K921265 · Shield Diagnostics, Ltd. · Aug 1992
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
K911661 · Immuno Concepts, Inc. · Dec 1991
QUANTA LITE(TM) ACA
K911680 · Inova Diagnostics, Inc. · Nov 1991