Cleared Traditional

K896868 - OPUS PHENYTOIN TEST SYSTEM

K896868 is an FDA 510(k) clearance for OPUS PHENYTOIN TEST SYSTEM, manufactured by Pb Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LGR cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K896868 · Pb Diagnostic Systems, Inc. · Toxicology device
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Jan 1990
Decision
26d
Days
Class 2
Risk

K896868 is an FDA 510(k) clearance for the OPUS PHENYTOIN TEST SYSTEM. Classified as Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (product code LGR), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on January 2, 1990 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3350 - 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 Pb Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K896868

510(k) Number K896868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1989
Decision Date January 02, 1990
Days to Decision 26 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 87d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGR Device Classification - Class 2, Special Controls

Product Code LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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 - LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)

All 13
Devices cleared under the same product code (LGR) and FDA review panel - the closest regulatory comparables to K896868.
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
K943313 · Sigma Diagnostics, Inc. · Oct 1994
AXSYM PHENYTOIN ASSAY
K935375 · Abbott Laboratories · Jun 1994
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
K936131 · Roche Diagnostic Systems, Inc. · Mar 1994
INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
K895827 · Innotron of Oregon, Inc. · Oct 1989
INNOTRON INNOFLUOR PHEYTOIN REAGENT SET
K872563 · Innotron of Oregon, Inc. · Aug 1987
IMMPULSE PHENYTOIN ASSAY REAGENT
K862554 · Sclavo, Inc. · Jul 1986