Cleared Traditional

K944192 - ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/...

K944192 is an FDA 510(k) clearance for ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/..., manufactured by Light Diagnostics. The device is a Class 2 Immunology device with product code DBL cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K944192 · Light Diagnostics · Immunology device
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Mar 1995
Decision
189d
Days
Class 2
Risk

K944192 is an FDA 510(k) clearance for the ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER. Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), Class II - Special Controls.

Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on March 6, 1995 after a review of 189 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 Light Diagnostics devices

FDA 510(k) Submission Details - K944192

510(k) Number K944192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1994
Decision Date March 06, 1995
Days to Decision 189 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
85d slower than avg
Panel avg: 104d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBL Device Classification - Class 2, Special Controls

Product Code DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
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 - DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

All 14
Devices cleared under the same product code (DBL) and FDA review panel - the closest regulatory comparables to K944192.
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ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER
K944191 · Light Diagnostics · Mar 1995
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K913360 · Immco Diagnostics, Inc. · Sep 1994
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K912551 · Immco Diagnostics, Inc. · Jun 1993
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K902237 · Medica Corp. · Jul 1990