Cleared Traditional

K813405 - AST(SGOT) IN VITRO DIAG. REAGENT SET

K813405 is the FDA 510(k) clearance for AST(SGOT) IN VITRO DIAG. REAGENT SET by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K813405 · Pointe Scientific, Inc., · Chemistry device
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Dec 1981
Decision
15d
Days
Class 2
Risk

K813405 is an FDA 510(k) clearance for the AST(SGOT) IN VITRO DIAG. REAGENT SET. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Mchenry, US). The FDA issued a Cleared decision on December 22, 1981 after a review of 15 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K813405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1981
Decision Date December 22, 1981
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 K813405.
BECKMAN LIQUID-STAT AST-UV LIQUID
K821433 · Beckman Instruments, Inc. · Jun 1982
ULTRAZYME PLUS GOT, #64953,65033&65034
K821467 · Emd Chemicals, Inc. · Jun 1982
RAICHEM GOT (AST) REAGENT
K820270 · Reagents Applications, Inc. · Feb 1982
ULTRA ZYME PLUS GOT #64953, 65033 & 34
K812592 · Harleco · Sep 1981
AST (UV) TEST
K810390 · Boehringer Mannheim Corp. · Feb 1981
CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
K803216 · Union Carbide Corp. · Jan 1981