Cleared Traditional

K990625 - AUTOSTAT II ANTI-SM ELISA

K990625 is an FDA 510(k) clearance for AUTOSTAT II ANTI-SM ELISA, manufactured by Cogent Diagnotics , Ltd.. The device is a Class 2 Immunology device with product code LKP cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K990625 · Cogent Diagnotics , Ltd. · Immunology device
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Apr 1999
Decision
62d
Days
Class 2
Risk

K990625 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-SM ELISA. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on April 28, 1999 after a review of 62 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 Cogent Diagnotics , Ltd. devices

FDA 510(k) Submission Details - K990625

510(k) Number K990625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1999
Decision Date April 28, 1999
Days to Decision 62 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
43d faster than avg
Panel avg: 105d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKP Device Classification - Class 2, Special Controls

Product Code LKP Anti-sm 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 - LKP Anti-sm Antibody, Antigen And Control

All 20
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K990625.
VARELISA SM ANTIBODIES, MODEL 18296
K042629 · Sweden Diagnostics (Germany) GmbH · Dec 2004
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219 · Bio-Rad · Jan 2003
VARELISA SM ANTIBODIES
K000312 · Pharmacia & Upjohn Co. · Mar 2000
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K984479 · Bio-Rad · Dec 1998
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO
K983420 · Zeus Scientific, Inc. · Nov 1998
SERAQUEST ANTI-SM
K980540 · Quest Intl., Inc. · Jun 1998