Cleared Traditional

K862319 - HBDH (OPTIMIZED) REAGENT

K862319 is the FDA 510(k) clearance for HBDH (OPTIMIZED) REAGENT by Sigma Chemical Co.. It is a Class 1 Chemistry device (product code JMK) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K862319 · Sigma Chemical Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
19d
Days
Class 1
Risk

K862319 is an FDA 510(k) clearance for the HBDH (OPTIMIZED) REAGENT. Classified as Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase (product code JMK), Class I - General Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on July 7, 1986 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1380 - 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K862319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1986
Decision Date July 07, 1986
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JMK Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1380
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 - JMK Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase

All 11
Devices cleared under the same product code (JMK) and FDA review panel - the closest regulatory comparables to K862319.
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
K941427 · Teco Diagnostics · Mar 1995
RAICHEM X-HBDH REAGENT
K843774 · Reagents Applications, Inc. · Oct 1984
AHBD
K822739 · Gilford Diagnostics · Oct 1982
HBDH ENZYME KINETIC REAGENT SET
K781720 · Medical Analysis Systems, Inc. · Nov 1978
HBDH REAGENT SET
K780073 · Medical Analysis Systems, Inc. · Feb 1978
ULTRAZYME PLUS HBD
K780104 · Harleco · Feb 1978