Cleared Traditional

BIODEX ACT-O-KIT TSH-RIA- (K840088) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840088 · Biodan Medical Systems, Ltd. · Chemistry device
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May 1984
Decision
118d
Days
Class 2
Risk

K840088 is an FDA 510(k) clearance for the BIODEX ACT-O-KIT TSH-RIA-. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Biodan Medical Systems, Ltd. (Israel, IL). The FDA issued a Cleared decision on May 7, 1984 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 Biodan Medical Systems, Ltd. devices

Submission Details

510(k) Number K840088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1984
Decision Date May 07, 1984
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 70
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K840088.
TERUMO SENSIBEAD EIA TSH KIT
K850376 · Terumo Medical Corp. · Mar 1985
ABBOTT HTSH EIA DIAGNOSTIC KIT
K843540 · Abbott Laboratories · Nov 1984
BLOOD SPOT NEONATAL TSH RADIOIMMUNO
K841606 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1984
EPSILON TSH TEST KIT
K831972 · Beckman Instruments, Inc. · Sep 1983
HISH EIA DIAGNOSTIC KIT
K822827 · Abbott Laboratories · Oct 1982
QUANTIMUNE HTSH IRMA
K822291 · Bio-Rad · Aug 1982