Cleared Traditional

K884377 - ASPARTATE AMINOTRANSFERASE TEST ITEM NO...

K884377 is the FDA 510(k) clearance for ASPARTATE AMINOTRANSFERASE TEST ITEM NO... by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K884377 · Em Diagnostic Systems, Inc. · Chemistry device
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Dec 1988
Decision
57d
Days
Class 2
Risk

K884377 is an FDA 510(k) clearance for the ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654. 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 December 14, 1988 after a review of 57 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 K884377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1988
Decision Date December 14, 1988
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
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 K884377.
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891468 · Trace Scientific , Ltd. · May 1989
ASPARTATE AMINOTRANSFERASE (AST)
K884724 · Catachem, Inc. · Mar 1989
CLINISTAT SGOT (AST) REAGENT TEST
K885156 · Heraeus Kulzer, Inc. · Feb 1989
ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)
K880692 · Diagnostic Chemicals, Ltd. (Usa) · May 1988
ASPARTATE AMINOTRANSFERASE AST/SGOT
K875071 · Tech-Co, Inc. · Feb 1988
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
K874600 · Em Diagnostic Systems, Inc. · Jan 1988