Cleared Traditional

K962926 - ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ...

K962926 is the FDA 510(k) clearance for ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ... by American Laboratory Products Co., Ltd.. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K962926 · American Laboratory Products Co., Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
73d
Days
Class 2
Risk

K962926 is an FDA 510(k) clearance for the ORGENTEC ANTI-CARDIOLIPIN SCREEN 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 October 10, 1996 after a review of 73 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 American Laboratory Products Co., Ltd. devices

Submission Details

510(k) Number K962926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1996
Decision Date October 10, 1996
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 104d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 52
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K962926.
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
K971784 · Zeus Scientific, Inc. · Jul 1997
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
K970177 · Immco Diagnostics, Inc. · Jun 1997
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039 · Hemagen Diagnostics, Inc. · Jun 1997
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
K962469 · American Laboratory Products Co., Ltd. · Sep 1996
DIASTAT ANTI-CARDIOLIPIN KIT
K955303 · Shield Diagnostics, Ltd. · May 1996
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY
K955449 · American Laboratory Products Co., Ltd. · May 1996