Cleared Traditional

K912020 - ANTI-DNA MICROASSAY

K912020 is the FDA 510(k) clearance for ANTI-DNA MICROASSAY by Diamedix Corp.. It is a Class 2 Immunology device (product code LRM) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K912020 · Diamedix Corp. · Immunology device
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Sep 1991
Decision
139d
Days
Class 2
Risk

K912020 is an FDA 510(k) clearance for the ANTI-DNA MICROASSAY. Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 139 days - within the typical 510(k) review window.

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: 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 Diamedix Corp. devices

Submission Details

510(k) Number K912020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1991
Decision Date September 23, 1991
Days to Decision 139 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
35d slower than avg
Panel avg: 104d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRM Anti-dna Antibody (enzyme-labeled), Antigen, 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 - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 12
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K912020.
HYTEC AUTOMIMMUNE KIT (DS-DNA)
K954893 · Hycor Biomedical, Inc. · Mar 1996
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · Elias U.S.A., Inc. · Apr 1995
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031 · Elias U.S.A., Inc. · Mar 1995
ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)
K893036 · Amersham Corp. · Jun 1989