Cleared Traditional

K970177 - ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ...

K970177 is an FDA 510(k) clearance for ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ..., manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K970177 · Immco Diagnostics, Inc. · Immunology device
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Jun 1997
Decision
145d
Days
Class 2
Risk

K970177 is an FDA 510(k) clearance for the ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on June 11, 1997 after a review of 145 days - within the typical 510(k) review window.

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 Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K970177

510(k) Number K970177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1997
Decision Date June 11, 1997
Days to Decision 145 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
41d slower than avg
Panel avg: 104d · This submission: 145d
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 K970177.
ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
K981020 · Zeus Scientific, Inc. · May 1998
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
K973196 · Zeus Scientific, Inc. · Oct 1997
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
K971784 · Zeus Scientific, Inc. · Jul 1997
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039 · Hemagen Diagnostics, Inc. · Jun 1997
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