Cleared Traditional

K034000 - VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR

K034000 is an FDA 510(k) clearance for VITALAB TRIGLYCERIDES REAGENT AND VITAL..., manufactured by Clinical Data, Inc.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K034000 · Clinical Data, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
77d
Days
Class 1
Risk

K034000 is an FDA 510(k) clearance for the VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on March 10, 2004 after a review of 77 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K034000

510(k) Number K034000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date March 10, 2004
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Entela, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 132
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