Cleared Traditional

K810390 - AST (UV) TEST

K810390 is an FDA 510(k) clearance for AST (UV) TEST, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810390 · Boehringer Mannheim Corp. · Chemistry device
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Feb 1981
Decision
13d
Days
Class 2
Risk

K810390 is an FDA 510(k) clearance for the AST (UV) TEST. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1981 after a review of 13 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K810390

510(k) Number K810390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1981
Decision Date February 23, 1981
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIT Device Classification - Class 2, Special Controls

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 110
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K810390.
AST(SGOT) IN VITRO DIAG. REAGENT SET
K813405 · Pointe Scientific, Inc., · Dec 1981
ULTRA ZYME PLUS GOT #64953, 65033 & 34
K812592 · Harleco · Sep 1981
GOT ISOENZYME ASSAY EIKEN KIT
K802447 · Syn-Kit, Inc. · Apr 1981
CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
K803216 · Union Carbide Corp. · Jan 1981
DATA-ZYME AST(GOT) PROCEDURE
K801856 · Data Medical Associates, Inc. · Sep 1980
CENTRIFI CHEM AST/SGOT
K800641 · Union Carbide Corp. · Apr 1980