Cleared Traditional

K861792 - TWIN GOT-AST IFCC/GPT-ALT IFCC

K861792 is an FDA 510(k) clearance for TWIN GOT-AST IFCC/GPT-ALT IFCC, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K861792 · Boehringer Mannheim Corp. · Chemistry device
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Jul 1986
Decision
81d
Days
Class 1
Risk

K861792 is an FDA 510(k) clearance for the TWIN GOT-AST IFCC/GPT-ALT IFCC. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 29, 1986 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 - K861792

510(k) Number K861792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1986
Decision Date July 29, 1986
Days to Decision 81 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
7d faster than avg
Panel avg: 88d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

CKA Device Classification - Class 1, General Controls

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 102
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K861792.
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · Em Diagnostic Systems, Inc. · Nov 1986
ALT/GPT PROCEDURE
K863253 · Data Medical Associates, Inc. · Sep 1986
MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT
K862833 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1986
ALT (SGPT) REAGENT SET (UV RATE)
K862209 · Sterling Diagnostics, Inc. · Jun 1986
ALT/GPT PROCEDURE
K861658 · Data Medical Associates, Inc. · May 1986
ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)
K861231 · Hi Chem, Inc. · Apr 1986