Cleared Traditional

K955449 - ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY

K955449 is an FDA 510(k) clearance for ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY, manufactured by American Laboratory Products Co., Ltd.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K955449 · American Laboratory Products Co., Ltd. · Immunology device
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May 1996
Decision
176d
Days
Class 2
Risk

K955449 is an FDA 510(k) clearance for the ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by American Laboratory Products Co., Ltd. (Windham, US). The FDA issued a Cleared decision on May 23, 1996 after a review of 176 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 American Laboratory Products Co., Ltd. devices

FDA 510(k) Submission Details - K955449

510(k) Number K955449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1995
Decision Date May 23, 1996
Days to Decision 176 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
71d slower than avg
Panel avg: 105d · This submission: 176d
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 K955449.
ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
K962926 · American Laboratory Products Co., Ltd. · Oct 1996
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
K962469 · American Laboratory Products Co., Ltd. · Sep 1996
DIASTAT ANTI-CARDIOLIPIN KIT
K955303 · Shield Diagnostics, Ltd. · May 1996
CARDIOLIPIN IGM EIA TEST SYSTEM
K952521 · Immunoprobe, Inc. · Feb 1996
CARDIOLIPIN IGA EIA TEST SYSTEM
K952522 · Immunoprobe, Inc. · Feb 1996
CARDIOLIPIN IGG EIA TEST KIT
K952523 · Immunoprobe, Inc. · Feb 1996