Cleared Traditional

K883742 - MODIFIED TSH IRMA KIT

K883742 is the FDA 510(k) clearance for MODIFIED TSH IRMA KIT by Pacific Biotech, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K883742 · Pacific Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
124d
Days
Class 2
Risk

K883742 is an FDA 510(k) clearance for the MODIFIED TSH IRMA KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Pacific Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on January 3, 1989 after a review of 124 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 Pacific Biotech, Inc. devices

Submission Details

510(k) Number K883742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1988
Decision Date January 03, 1989
Days to Decision 124 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 88d · This submission: 124d
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 146
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K883742.
COTUBE(TM) TSH IRMA
K890802 · Bio-Rad · Mar 1989
TSH MICROASSAY
K890579 · Diamedix Corp. · Mar 1989
VENTREX COATED TUBE HIGH SENSITIVITY TSH
K885157 · Ventrex Laboratories, Inc. · Feb 1989
DELFIA(TM) NEONATAL HTSH KIT
K881627 · Pharmacia, Inc. · Oct 1988
AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
K882907 · Amersham Corp. · Sep 1988
VENTREX COATED TUBE TSH
K883342 · Ventrex Laboratories, Inc. · Sep 1988