Cleared Traditional

K950028 - PRIMIDONE FPIA REAGENT SET AND CALIBRATORS

K950028 is the FDA 510(k) clearance for PRIMIDONE FPIA REAGENT SET AND CALIBRATORS by Sigma Diagnostics, Inc.. It is a Class 2 Toxicology device (product code LFT) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K950028 · Sigma Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
76d
Days
Class 2
Risk

K950028 is an FDA 510(k) clearance for the PRIMIDONE FPIA REAGENT SET AND CALIBRATORS. Classified as Fluorescent Immunoassay, Primidone (product code LFT), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3680 - the FDA toxicology device 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K950028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1995
Decision Date March 21, 1995
Days to Decision 76 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 87d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFT Fluorescent Immunoassay, Primidone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - LFT Fluorescent Immunoassay, Primidone

Devices cleared under the same product code (LFT) and FDA review panel - the closest regulatory comparables to K950028.
STRATUS PRIMIDONE FLUOROMETRIC ENZYME
K904683 · Baxter Healthcare Corp · Nov 1990
COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
K852318 · Roche Diagnostic Systems, Inc. · Jun 1985
STRATUS PRIMIDONE FLOROMETRIC ENZY
K842196 · American Dade · Jul 1984
ADVANCE EMIT-AED PRIMEDONE ASSAY
K823741 · Syva Co. · Jan 1983
PRIMIDONE FLUORESCENT IMMUNOASSAY
K822229 · American Diagnostic Corp. · Aug 1982
AMES TDA TM PRIMIDONE TEST
K811007 · Miles Laboratories, Inc. · Apr 1981