Cleared Traditional

K913342 - AUTOSTAT(TM) ANTI-DSNA

K913342 is an FDA 510(k) clearance for AUTOSTAT(TM) ANTI-DSNA, manufactured by Cogent Diagnotics , Ltd.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K913342 · Cogent Diagnotics , Ltd. · Immunology device
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May 1992
Decision
280d
Days
Class 2
Risk

K913342 is an FDA 510(k) clearance for the AUTOSTAT(TM) ANTI-DSNA. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Dunblane, Fk15 9ep, GB). The FDA issued a Cleared decision on May 1, 1992 after a review of 280 days - an extended review 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: 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 - K913342

510(k) Number K913342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1991
Decision Date May 01, 1992
Days to Decision 280 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
175d slower than avg
Panel avg: 105d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

Product Code LKJ Antinuclear Antibody, 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 - LKJ Antinuclear Antibody, Antigen, Control

All 36
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K913342.
SYLNELISA HISTONE ANTIBODIES
K932302 · Elias U.S.A., Inc. · Aug 1993
SYN ELISA DSDNA ANTIBODIES
K921132 · Elias U.S.A., Inc. · Dec 1992
THE THERATEST EL-ANA PROFILES
K914454 · Theratest Laboratories, Inc. · May 1992
DISTAT ANTI-SCL-70 KIT
K912291 · Shield Diagnostics, Ltd. · Jul 1991
SERATEST ENA [SCL-70] KIT
K894411 · Hemagen Diagnostics, Inc. · Aug 1989
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883 · Immco Diagnostics, Inc. · Oct 1988