Cleared Traditional

K912020 - ANTI-DNA MICROASSAY

K912020 is an FDA 510(k) clearance for ANTI-DNA MICROASSAY, manufactured by Diamedix Corp.. The device is a Class 2 Immunology device with 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.

FDA 510(k) Submission Details - K912020

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
34d slower than avg
Panel avg: 105d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRM Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K912020.
SELISA ANTI-N DNA ANTIBODIES
K940585 · Cambridge Life Sciences Plc. · Jun 1994
ENCORE DS-DNA
K923537 · Clark Laboratories, Inc. · Dec 1992
3M ANTI-DSDNA FAST TEST
K913653 · 3M Diagnostic Systems, Inc. · Nov 1991
UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE
K902897 · United Biotech, Inc. · Jul 1990
ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)
K893036 · Amersham Corp. · Jun 1989
NDNA ANTIBODY TEST KIT
K874191 · Lipogen, Inc. · Dec 1987
K912020 · ANTI-DNA MICROASSAY
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