Cleared Traditional

K821805 - PYRIDOXAL-5-PHOSPHATE STRIPES

K821805 is an FDA 510(k) clearance for PYRIDOXAL-5-PHOSPHATE STRIPES, 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 15-day FDA review.

K821805 · Boehringer Mannheim Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 1982
Decision
15d
Days
Class 1
Risk

K821805 is an FDA 510(k) clearance for the PYRIDOXAL-5-PHOSPHATE STRIPES. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 - K821805

510(k) Number K821805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1982
Decision Date July 02, 1982
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.

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 K821805.
ALT -LTS
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ALT ENZYME ASSAY KIT
K821946 · Travenol Laboratories, S.A. · Jul 1982
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K821048 · Beckman Instruments, Inc. · May 1982
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K820525 · Reagents Applications, Inc. · Mar 1982
TECHNICON RA-1000 SYSTEM ADD. ANALYT
K820394 · Technicon Instruments Corp. · Mar 1982