Cleared Traditional

K970239 - IS-ANTI-SCL-70 TEST SYSTEM (720-280)

K970239 is the FDA 510(k) clearance for IS-ANTI-SCL-70 TEST SYSTEM (720-280) by Diamedix Corp.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K970239 · Diamedix Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
77d
Days
Class 2
Risk

K970239 is an FDA 510(k) clearance for the IS-ANTI-SCL-70 TEST SYSTEM (720-280). Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on April 8, 1997 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

Submission Details

510(k) Number K970239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1997
Decision Date April 08, 1997
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
27d faster than avg
Panel avg: 104d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 106
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K970239.
IS-ANTI-JO-1 TEST SYSTEM
K970228 · Diamedix Corp. · Apr 1997
IS-ANTI-SSB TEST SYSTEM (720-260)
K970237 · Diamedix Corp. · Apr 1997
IS-ANTI-SM/RNP (720-270)
K970238 · Diamedix Corp. · Apr 1997
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
K962578 · Hycor Biomedical, Inc. · Mar 1997
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
K962719 · Hycor Biomedical, Inc. · Mar 1997
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
K962720 · Hycor Biomedical, Inc. · Mar 1997