Cleared Traditional

K893620 - T3 CLASP-BEAD EIA KIT

K893620 is an FDA 510(k) clearance for T3 CLASP-BEAD EIA KIT, manufactured by Biotecx Laboratories, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K893620

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.

CDP Device Classification - Class 2, Special Controls

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 119
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K893620.
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K883810 · Pharmacia, Inc. · Dec 1988
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K883479 · Baxter Healthcare Corp · Oct 1988