Cleared Traditional

K841706 - INNOFLUOR PHENYTOIN

K841706 is an FDA 510(k) clearance for INNOFLUOR PHENYTOIN, manufactured by Innotron Diagnostics. The device is a Class 2 Chemistry device with product code LGR cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K841706 · Innotron Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1984
Decision
29d
Days
Class 2
Risk

K841706 is an FDA 510(k) clearance for the INNOFLUOR PHENYTOIN. Classified as Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (product code LGR), Class II - Special Controls.

Submitted by Innotron Diagnostics (Walker, US). The FDA issued a Cleared decision on May 22, 1984 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3350 - 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 Innotron Diagnostics devices

FDA 510(k) Submission Details - K841706

510(k) Number K841706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date May 22, 1984
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)

All 14
Devices cleared under the same product code (LGR) and FDA review panel - the closest regulatory comparables to K841706.
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR
K843824 · Roche Diagnostic Systems, Inc. · Feb 1985
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