Cleared Traditional

K914801 - IMMUNOWELL DSDNA ANTIBODY TEST

K914801 is an FDA 510(k) clearance for IMMUNOWELL DSDNA ANTIBODY TEST, manufactured by General Biometrics, Inc.. The device is a Class 2 Immunology device with product code DHC cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K914801 · General Biometrics, Inc. · Immunology device
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Dec 1991
Decision
46d
Days
Class 2
Risk

K914801 is an FDA 510(k) clearance for the IMMUNOWELL DSDNA ANTIBODY TEST. Classified as System, Test, Systemic Lupus Erythematosus (product code DHC), Class II - Special Controls.

Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5820 - 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 General Biometrics, Inc. devices

FDA 510(k) Submission Details - K914801

510(k) Number K914801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1991
Decision Date December 09, 1991
Days to Decision 46 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
58d faster than avg
Panel avg: 104d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHC Device Classification - Class 2, Special Controls

Product Code DHC System, Test, Systemic Lupus Erythematosus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5820
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 - DHC System, Test, Systemic Lupus Erythematosus

All 11
Devices cleared under the same product code (DHC) and FDA review panel - the closest regulatory comparables to K914801.
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ELIAS DSDNA ABS
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K821385 · Texas Immunology, Inc. · May 1982
SLE ANTI-N-DNA LATEX TEST
K810226 · Icl Scientific · Feb 1981
CORDIA N
K800991 · Cordis Corp. · May 1980