Cleared Traditional

K862832 - MODEL 303-42/303-43 ASPARTATE AMINOTRAN...

K862832 is the FDA 510(k) clearance for MODEL 303-42/303-43 ASPARTATE AMINOTRAN... by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K862832 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Aug 1986
Decision
18d
Days
Class 2
Risk

K862832 is an FDA 510(k) clearance for the MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on August 12, 1986 after a review of 18 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K862832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1986
Decision Date August 12, 1986
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
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 106
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K862832.
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
K863963 · Em Diagnostic Systems, Inc. · Nov 1986
AST/GOT PROCEDURE
K863257 · Data Medical Associates, Inc. · Sep 1986
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
K863094 · Em Diagnostic Systems, Inc. · Aug 1986
AST/GOT PROCEDURE
K861656 · Data Medical Associates, Inc. · May 1986
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
K860465 · Abbott Laboratories · May 1986
AST REAGENT CARTRIDGE
K861283 · Hi Chem, Inc. · Apr 1986