Cleared Traditional

K931257 - ACETASITE

K931257 is an FDA 510(k) clearance for ACETASITE, manufactured by Gds Diagnostics. The device is a Class 2 Toxicology device with product code LDP cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K931257 · Gds Diagnostics · Toxicology device
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Jul 1993
Decision
118d
Days
Class 2
Risk

K931257 is an FDA 510(k) clearance for the ACETASITE. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Gds Diagnostics (Elkhart, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3030 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gds Diagnostics devices

FDA 510(k) Submission Details - K931257

510(k) Number K931257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1993
Decision Date July 08, 1993
Days to Decision 118 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 87d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDP Device Classification - Class 2, Special Controls

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
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 Toxicology devices follow this clearance model.

Regulatory Peers - LDP Colorimetry, Acetaminophen

All 32
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K931257.
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
K954933 · Johnson & Johnson Clinical Diagnostics, Inc. · Dec 1995
ACETAMINOPHEN ASSAY
K952949 · Diagnostic Chemicals , Ltd. · Sep 1995
AXSYM ACETAMINOPHEN
K953094 · Abbott Laboratories · Aug 1995
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1989
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · Em Diagnostic Systems, Inc. · Aug 1988
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
K851278 · Stanbio Laboratory · Apr 1985