Cleared Traditional

K874835 - PYRIDOXAL-5-PHOSPHATE TABLETS

K874835 is an FDA 510(k) clearance for PYRIDOXAL-5-PHOSPHATE TABLETS, 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 58-day FDA review.

K874835 · Boehringer Mannheim Corp. · Chemistry device
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Jan 1988
Decision
58d
Days
Class 1
Risk

K874835 is an FDA 510(k) clearance for the PYRIDOXAL-5-PHOSPHATE TABLETS. 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 January 21, 1988 after a review of 58 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 - K874835

510(k) Number K874835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1987
Decision Date January 21, 1988
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
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 K874835.
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
K883181 · Beckman Instruments, Inc. · Sep 1988
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
K875079 · Miles Laboratories, Inc. · Apr 1988
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
K874586 · Em Diagnostic Systems, Inc. · Jan 1988
MODIFIED ALT (GPT) REAGENT
K872483 · Trace Scientific , Ltd. · Aug 1987
BIOTROL ALT/TGP MONOREACTIF
K872830 · Biotrol, USA, Inc. · Aug 1987
ALANINE AMINOTRANSFERASE (ALT)/(GPT)
K870086 · Catachem, Inc. · Mar 1987