Cleared Traditional

K840088 - BIODEX ACT-O-KIT TSH-RIA-

K840088 is an FDA 510(k) clearance for BIODEX ACT-O-KIT TSH-RIA-, manufactured by Biodan Medical Systems, Ltd.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 118-day FDA review.

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

FDA 510(k) Submission Details - K840088

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.

JLW Device Classification - Class 2, Special Controls

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 158
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K840088.
TSH QUIK RIA KIT
K843545 · Pacific Biotech, Inc. · Oct 1984
AMERLEX-M TSH RIA
K842948 · Amersham Corp. · Sep 1984
BLOOD SPOT NEONATAL TSH RADIOIMMUNO
K841606 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1984
TANDEM-E THYROID STIMULATING HORMONE KIT
K832813 · Hybritech, Inc. · Oct 1983
ENZYMUNE-TEST TSH
K832823 · Icl Scientific · Oct 1983
EPSILON TSH TEST KIT
K831972 · Beckman Instruments, Inc. · Sep 1983