Cleared Traditional

K771474 - MULTISTAT III X-HBDH TEST

K771474 is the FDA 510(k) clearance for MULTISTAT III X-HBDH TEST by Instrumentation Laboratory CO. It is a Class 1 Chemistry device (product code JMK) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K771474 · Instrumentation Laboratory CO · Chemistry device
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Sep 1977
Decision
40d
Days
Class 1
Risk

K771474 is an FDA 510(k) clearance for the MULTISTAT III X-HBDH TEST. Classified as Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase (product code JMK), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on September 13, 1977 after a review of 40 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K771474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1977
Decision Date September 13, 1977
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
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 9
Devices cleared under the same product code (JMK) and FDA review panel - the closest regulatory comparables to K771474.
ULTRAZYME PLUS HBD
K780104 · Harleco · Feb 1978
HYDORRYBUTYRATE DEHYDROGENASE
K780042 · Beckman Instruments, Inc. · Feb 1978
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
K772033 · Harleco · Nov 1977
ULTRAZYME PLUS HBD
K770871 · Harleco · Jul 1977
ULTRAZYME HBD
K760023 · Harleco · Aug 1976