Cleared Traditional

K781477 - TRIGLYCERIDES TEST KIT

K781477 is the FDA 510(k) clearance for TRIGLYCERIDES TEST KIT by Mallinckrodt Critical Care. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K781477 · Mallinckrodt Critical Care · Chemistry device
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Oct 1978
Decision
36d
Days
Class 1
Risk

K781477 is an FDA 510(k) clearance for the TRIGLYCERIDES TEST KIT. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 36 days - a notably fast clearance cycle.

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: 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K781477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1978
Decision Date October 03, 1978
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 115
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K781477.
ENZYMATIC TRIGLYCERIDES-S.V.R.
K790773 · Calbiochem-Behring Corp. · Jun 1979
REAGENT KIT, TRIGLYCERIDES
K781939 · Beckman Instruments, Inc. · Jan 1979
AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT
K781466 · Fisher Scientific Co., LLC · Oct 1978
ENZYMATIC TRIGLYCERIDES REAGENT KIT
K781240 · J.T. Baker Chemical Co. · Aug 1978
DATA-ZYME TRIGLYCERIDE PROCEDURE
K780379 · Data Medical Associates, Inc. · May 1978
TRIGLYCERIDE INSTRUMENT APPLICATION
K780172 · Harleco · Mar 1978