Cleared Traditional

K843824 - COBAS FP REAGENTS FOR PHENYTOIN & CALIBR

K843824 is an FDA 510(k) clearance for COBAS FP REAGENTS FOR PHENYTOIN & CALIBR, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LGR cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K843824 · Roche Diagnostic Systems, Inc. · Toxicology device
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Feb 1985
Decision
126d
Days
Class 2
Risk

K843824 is an FDA 510(k) clearance for the COBAS FP REAGENTS FOR PHENYTOIN & CALIBR. Classified as Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (product code LGR), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K843824

510(k) Number K843824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1984
Decision Date February 01, 1985
Days to Decision 126 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
39d slower than avg
Panel avg: 87d · This submission: 126d
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 K843824.
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
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE
K844171 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984
PHENYTOIN KIT FLUORESCENCE POLARIZATION
K842586 · Windsor Laboratories, Inc. · Sep 1984