Cleared Traditional

K922857 - SYSTAMATE ASPARTATE AMINOTRANSFERASE TE...

K922857 is the FDA 510(k) clearance for SYSTAMATE ASPARTATE AMINOTRANSFERASE TE... by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K922857 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1992
Decision
86d
Days
Class 2
Risk

K922857 is an FDA 510(k) clearance for the SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 9, 1992 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - the FDA in vitro diagnostics and chemistry 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K922857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1992
Decision Date September 09, 1992
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
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 Chemistry devices follow this clearance model.

Regulatory Peers - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 104
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K922857.
ROCHE REAGENT FOR AST
K924244 · Roche Diagnostic Systems, Inc. · Jan 1993
AST (GOT) - ASPARTATE AMINOTRANSFERASE
K923505 · Randox Laboratories, Ltd. · Nov 1992
IL TEST AST, PN 35312
K923641 · Instrumentation Laboratory CO · Oct 1992
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
K922885 · Olympus Corp. · Jul 1992
KING DIAGNOSTICS AST (GOT) REAGENT
K922108 · King Diagnostics, Inc. · Jul 1992
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
K920336 · Heraeus Kulzer, Inc. · Mar 1992