Cleared Traditional

K052301 - FASTPACK TSH IMMUNOASSAY

K052301 is an FDA 510(k) clearance for FASTPACK TSH IMMUNOASSAY, manufactured by Qualigen, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K052301 · Qualigen, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
135d
Days
Class 2
Risk

K052301 is an FDA 510(k) clearance for the FASTPACK TSH IMMUNOASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Qualigen, Inc. (Carlsbad, US). The FDA issued a Cleared decision on January 4, 2006 after a review of 135 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 Qualigen, Inc. devices

FDA 510(k) Submission Details - K052301

510(k) Number K052301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2005
Decision Date January 04, 2006
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
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 K052301.
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
K081074 · Siemens Healthcare Diagnostics, Inc. · May 2008
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
K062581 · Olympus America, Inc. · Nov 2006
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
K060090 · Dade Behring, Inc. · Feb 2006
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
K042281 · Beckman Coulter, Inc. · Sep 2004
TSH-CTK-3 IRMA
K041014 · DiaSorin, Inc. · Jul 2004
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · Beckman Coulter, Inc. · Nov 2002