Cleared Traditional

K902915 - ANTI-SCI-70 MICROASSAY

K902915 is an FDA 510(k) clearance for ANTI-SCI-70 MICROASSAY, manufactured by Diamedix Corp.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K902915 · Diamedix Corp. · Immunology device
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Sep 1990
Decision
65d
Days
Class 2
Risk

K902915 is an FDA 510(k) clearance for the ANTI-SCI-70 MICROASSAY. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 65 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 Diamedix Corp. devices

FDA 510(k) Submission Details - K902915

510(k) Number K902915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date September 06, 1990
Days to Decision 65 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
40d faster than avg
Panel avg: 105d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 77
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K902915.
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
K915272 · Hemagen Diagnostics, Inc. · Mar 1992
UBI MAGIWEL(TM) ANA QUANTITATIVE
K910033 · United Biotech, Inc. · Jan 1991
DIASTAT ENA PROFILE
K905190 · Shield Diagnostics, Ltd. · Dec 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2
K900072 · General Biometrics, Inc. · Jan 1990
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
K896347 · General Biometrics, Inc. · Dec 1989
ANTI-SM MICROASSAY
K894894 · Diamedix Corp. · Aug 1989