Cleared Traditional

K810965 - DATA-ZYME TRIGLYCERIDE

K810965 is the FDA 510(k) clearance for DATA-ZYME TRIGLYCERIDE by Data Medical Associates, Inc.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K810965 · Data Medical Associates, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
9d
Days
Class 1
Risk

K810965 is an FDA 510(k) clearance for the DATA-ZYME TRIGLYCERIDE. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 9 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K810965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1981
Decision Date April 17, 1981
Days to Decision 9 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
79d faster than avg
Panel avg: 88d · This submission: 9d
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 112
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K810965.
SPIN-CHEM TRIGLYCERIDES REAGENT
K812471 · Smithkline Diagnostics, Inc. · Sep 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)
K812029 · Eastman Kodak Company · Aug 1981
ESKAFLOW TEST FOR TRIGLYCERIDES
K811850 · Smithkline Diagnostics, Inc. · Jul 1981
ENZYMATIC TRIGLYCERIDE
K810680 · Pointe Scientific, Inc., · Mar 1981
LUQUIZYME TRIGLYCERIDE REAGENT SET
K803297 · Amresco, Inc. · Jan 1981
TRIGLYCERIDES (UV)-2 REAGENTS
K803091 · Reagents Applications, Inc. · Jan 1981