Cleared Traditional

K952751 - BIOCIRCUITS IOS T4/TU TEST CARTRIDGES

K952751 is an FDA 510(k) clearance for BIOCIRCUITS IOS T4/TU TEST CARTRIDGES, manufactured by Biocircuits Corp.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K952751 · Biocircuits Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
158d
Days
Class 2
Risk

K952751 is an FDA 510(k) clearance for the BIOCIRCUITS IOS T4/TU TEST CARTRIDGES. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Biocircuits Corp. (Sunnyvale, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 158 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biocircuits Corp. devices

FDA 510(k) Submission Details - K952751

510(k) Number K952751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1995
Decision Date November 20, 1995
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 88d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLI Device Classification - Class 2, Special Controls

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 70
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K952751.
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
K964721 · Johnson & Johnson Clinical Diagnostics, Inc. · Dec 1996
ISOLAB'S T4 TEST KIT
K951014 · Isolab, Inc. · Oct 1996
UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
K962211 · United Biotech, Inc. · Jul 1996
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · Bio-Rad · Aug 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K946163 · Bio-Rad · Feb 1995
THYROXINE ENZYME IMMUNOASSAY
K944703 · Diagnostic Reagents, Inc. · Dec 1994