Cleared Traditional

K923508 - TRIGLYCERIDES GPO-PAP

K923508 is an FDA 510(k) clearance for TRIGLYCERIDES GPO-PAP, manufactured by Randox Laboratories, Ltd.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K923508 · Randox Laboratories, Ltd. · Chemistry device
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Jul 1993
Decision
378d
Days
Class 1
Risk

K923508 is an FDA 510(k) clearance for the TRIGLYCERIDES GPO-PAP. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on July 28, 1993 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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.

View all Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K923508

510(k) Number K923508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1992
Decision Date July 28, 1993
Days to Decision 378 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 88d · This submission: 378d
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
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