Cleared Traditional

K893620 - T3 CLASP-BEAD EIA KIT

K893620 is the FDA 510(k) clearance for T3 CLASP-BEAD EIA KIT by Biotecx Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K893620 · Biotecx Laboratories, Inc. · Chemistry device
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Aug 1989
Decision
92d
Days
Class 2
Risk

K893620 is an FDA 510(k) clearance for the T3 CLASP-BEAD EIA KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on August 11, 1989 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Biotecx Laboratories, Inc. devices

Submission Details

510(k) Number K893620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1989
Decision Date August 11, 1989
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 94
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K893620.
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K885195 · Amersham Corp. · Feb 1989
DELFIA TRIIODOTHYRONINE (T3) KIT
K883810 · Pharmacia, Inc. · Dec 1988
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME
K883479 · Baxter Healthcare Corp · Oct 1988