Cleared Traditional

K930010 - ACCESS THYROID UPTAKE ASSAY

K930010 is an FDA 510(k) clearance for ACCESS THYROID UPTAKE ASSAY, manufactured by Bio-Rad Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CEE cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K930010 · Bio-Rad Laboratories, Inc. · Chemistry device
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Jun 1993
Decision
154d
Days
Class 2
Risk

K930010 is an FDA 510(k) clearance for the ACCESS THYROID UPTAKE ASSAY. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on June 7, 1993 after a review of 154 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1685 - 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 Bio-Rad Laboratories, Inc. devices

FDA 510(k) Submission Details - K930010

510(k) Number K930010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1993
Decision Date June 07, 1993
Days to Decision 154 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 88d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEE Device Classification - Class 2, Special Controls

Product Code CEE Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1685
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 - CEE Radioimmunoassay, Thyroxine-binding Globulin

All 22
Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K930010.
AMERLITE TBG ASSAY
K952284 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
K905777 · Immunotech Corp. · Jan 1991
DELFIA TBG KIT
K900240 · Pharmacia, Inc. · Mar 1990
ENZYMUN TEST(R) TBK
K896991 · Boehringer Mannheim Corp. · Mar 1990
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
K893469 · Amersham Corp. · Aug 1989
T-UPTAKE MICROASSAY
K885034 · Diamedix Corp. · Feb 1989