Cleared Traditional

K780636 - SINGLE VIAL 10 SGPT-TRIS

K780636 is an FDA 510(k) clearance for SINGLE VIAL 10 SGPT-TRIS, 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 31-day FDA review.

K780636 · Boehringer Mannheim Corp. · Chemistry device
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May 1978
Decision
31d
Days
Class 1
Risk

K780636 is an FDA 510(k) clearance for the SINGLE VIAL 10 SGPT-TRIS. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on May 18, 1978 after a review of 31 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 - K780636

510(k) Number K780636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1978
Decision Date May 18, 1978
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 K780636.
SERUM, GLUTAMIC-PYRUVIC
K790016 · Fisher Scientific Co., LLC · Feb 1979
REAGENT SET, SGPT SERUM GLUTAMIC
K781726 · Medical Analysis Systems, Inc. · Nov 1978
SGPT/ALT REAGENT SYSTEM
K780791 · American Monitor Corp. · Jun 1978
ALT(GPT) UNI-UV, SGPT
K780462 · Sclavo, Inc. · May 1978
STAC SYSTEM
K780373 · Technicon Instruments Corp. · Apr 1978
ULTRAZYME PLUS GPT
K780102 · Harleco · Feb 1978