Cleared Traditional

K902938 - IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3

K902938 is an FDA 510(k) clearance for IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3, manufactured by General Biometrics, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K902938 · General Biometrics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
37d
Days
Class 2
Risk

K902938 is an FDA 510(k) clearance for the IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 - K902938

510(k) Number K902938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date August 09, 1990
Days to Decision 37 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 104d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 132
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K902938.
HEMAGEN ENA SCREENING KIT
K910232 · Hemagen Diagnostics, Inc. · Mar 1991
QUANTA LITE TM DSDNA
K903898 · Inova Diagnostics, Inc. · Sep 1990
ANTI-SCI-70 ANTIBODY TEST
K903314 · Immco Diagnostics, Inc. · Aug 1990
IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4
K903047 · General Biometrics, Inc. · Aug 1990
READS(R) ANTI-ENA (SM/RNP) TEST KIT
K901924 · Biosearch Medical Products, Inc. · May 1990
REAADS ANTI-SM TEST KIT
K901230 · Biosearch Medical Products, Inc. · Mar 1990