Cleared Traditional

K954187 - TRIGLYCERIDES REAGENT

K954187 is an FDA 510(k) clearance for TRIGLYCERIDES REAGENT, manufactured by Schiapparelli Biosystems, Inc.. The device is a Class 1 Chemistry device with product code JGY cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K954187 · Schiapparelli Biosystems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
47d
Days
Class 1
Risk

K954187 is an FDA 510(k) clearance for the TRIGLYCERIDES REAGENT. Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on October 23, 1995 after a review of 47 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 Schiapparelli Biosystems, Inc. devices

FDA 510(k) Submission Details - K954187

510(k) Number K954187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date October 23, 1995
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

JGY Device Classification - Class 1, General Controls

Product Code JGY Colorimetric Method, 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 - JGY Colorimetric Method, Triglycerides

All 13
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