Cleared Traditional

K881381 - REAGENTS FOR TSH ASSAY

K881381 is an FDA 510(k) clearance for REAGENTS FOR TSH ASSAY, manufactured by Sclavo, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K881381 · Sclavo, Inc. · Chemistry device
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Jul 1988
Decision
111d
Days
Class 2
Risk

K881381 is an FDA 510(k) clearance for the REAGENTS FOR TSH ASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Sclavo, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 21, 1988 after a review of 111 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 Sclavo, Inc. devices

FDA 510(k) Submission Details - K881381

510(k) Number K881381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1988
Decision Date July 21, 1988
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 88d · This submission: 111d
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 200
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K881381.
DELFIA(TM) NEONATAL HTSH KIT
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ABBOTT IMX HTSH
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FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301
K874622 · Cyberfluor, Inc. · Dec 1987
TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093
K874061 · Medix Biotech, Inc. · Nov 1987