Cleared Traditional

K942117 - STA AUTOMATED MULTI-PARAMETRIC ANALYZER

K942117 is the FDA 510(k) clearance for STA AUTOMATED MULTI-PARAMETRIC ANALYZER by American Bioproducts Co.. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K942117 · American Bioproducts Co. · Hematology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
274d
Days
Class 2
Risk

K942117 is an FDA 510(k) clearance for the STA AUTOMATED MULTI-PARAMETRIC ANALYZER. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on February 1, 1995 after a review of 274 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Bioproducts Co. devices

Submission Details

510(k) Number K942117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1994
Decision Date February 01, 1995
Days to Decision 274 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 113d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKP Instrument, Coagulation, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 Hematology devices follow this clearance model.

Regulatory Peers - GKP Instrument, Coagulation, Automated

All 36
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K942117.
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PROTIME MICROCOAGULATION SYSTEM
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MICROSAMPLE COAGULATION ANALYZER
K943153 · Bio/Data Corp. · Mar 1995
HEMOLAB
K931992 · Biomerieux Vitek, Inc. · Dec 1994
CASCADE M, CAT. NO. 1710
K931956 · Helena Laboratories · Aug 1993
IL MCL-2 COAGULATION ANALYZER
K924098 · Instrumentation Laboratory CO · Jun 1993