Cleared Traditional

K941427 - SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) (FDA 510(k) Clearance)

Class I Chemistry device.

K941427 · Teco Diagnostics · Chemistry device
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Mar 1995
Decision
354d
Days
Class 1
Risk

K941427 is an FDA 510(k) clearance for the SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH). Classified as Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase (product code JMK), Class I - General Controls.

Submitted by Teco Diagnostics (Placentia, US). The FDA issued a Cleared decision on March 13, 1995 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K941427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1994
Decision Date March 13, 1995
Days to Decision 354 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
266d slower than avg
Panel avg: 88d · This submission: 354d
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.