Cleared Traditional

K974694 - IS-DSDNA TEST SYSTEM

K974694 is an FDA 510(k) clearance for IS-DSDNA TEST SYSTEM, 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 77-day FDA review.

K974694 · Diamedix Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Mar 1998
Decision
77d
Days
Class 2
Risk

K974694 is an FDA 510(k) clearance for the IS-DSDNA TEST SYSTEM. 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 March 3, 1998 after a review of 77 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 - K974694

510(k) Number K974694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1997
Decision Date March 03, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 105d · This submission: 77d
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 19
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K974694.
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
K984396 · Bio-Rad · Dec 1998
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
K983422 · Zeus Scientific, Inc. · Nov 1998
SERAQUEST ANTI-DSDNA
K980391 · Quest Intl., Inc. · Apr 1998
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
K962730 · Hycor Biomedical, Inc. · Mar 1997
AUTOSTATTMII ANTI-DSDNA
K952567 · Cogent Diagnotics , Ltd. · Mar 1997
HYTEC AUTOMIMMUNE KIT (DS-DNA)
K954893 · Hycor Biomedical, Inc. · Mar 1996