Cleared Traditional

K942661 - AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT

K942661 is an FDA 510(k) clearance for AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT, manufactured by Sealite Sciences, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K942661 · Sealite Sciences, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
225d
Days
Class 2
Risk

K942661 is an FDA 510(k) clearance for the AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Sealite Sciences, Inc. (Bogart, US). The FDA issued a Cleared decision on January 17, 1995 after a review of 225 days - an extended review cycle.

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 Sealite Sciences, Inc. devices

FDA 510(k) Submission Details - K942661

510(k) Number K942661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1994
Decision Date January 17, 1995
Days to Decision 225 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 88d · This submission: 225d
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 189
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K942661.
CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY
K950921 · Nichols Institute Diagnostics · May 1995
COAT-A-COUNT NEONATAL TSH IRMA
K943195 · Diagnostic Products Corp. · Mar 1995
NEOSCREEN ELISA TSH
K942658 · Pantex, Div. Bio-Analysis, Inc. · Feb 1995
IMMULITE RAPID TSH
K933212 · Diagnostic Products Corp. · Dec 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
K935399 · Bio-Rad · Dec 1994
IMMULITE THIRD GENERATION (MODIFICATION)
K940006 · Diagnostic Products Corp. · Dec 1994