Cleared Traditional

K771004 - AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI

K771004 is an FDA 510(k) clearance for AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI, manufactured by Miles Laboratories, Inc.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K771004 · Miles Laboratories, Inc. · Chemistry device
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Sep 1977
Decision
102d
Days
Class 1
Risk

K771004 is an FDA 510(k) clearance for the AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1977 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1705 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K771004

510(k) Number K771004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1977
Decision Date September 12, 1977
Days to Decision 102 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
14d slower than avg
Panel avg: 88d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

CDT Device Classification - Class 1, General Controls

Product Code CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1705
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 - CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 134
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K771004.
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TRIGLYCERIDE ENZYMATIC METHOD
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