Cleared Traditional

K983655 - AUTOSTAT II ANA SCREEN ELISA

K983655 is an FDA 510(k) clearance for AUTOSTAT II ANA SCREEN ELISA, manufactured by Cogent Diagnotics , Ltd.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K983655 · Cogent Diagnotics , Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
101d
Days
Class 2
Risk

K983655 is an FDA 510(k) clearance for the AUTOSTAT II ANA SCREEN ELISA. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on January 28, 1999 after a review of 101 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 Cogent Diagnotics , Ltd. devices

FDA 510(k) Submission Details - K983655

510(k) Number K983655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1998
Decision Date January 28, 1999
Days to Decision 101 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
4d faster than avg
Panel avg: 105d · This submission: 101d
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 79
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K983655.
VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96
K993108 · Pharmacia & Upjohn Co. · Nov 1999
VARELISA RECOMBI ANA PROFILE
K993109 · Pharmacia & Upjohn Co. · Nov 1999
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
K992041 · Immuno Concepts, Inc. · Jul 1999
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.
K983378 · Zeus Scientific, Inc. · Nov 1998
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
K980337 · Helix Diagnostics, Inc. · May 1998
SERAQUEST ANTI-SSA
K980810 · Quest Intl., Inc. · May 1998