Cleared Special

K101390 - FASTPACK TSH IMMUNOASSAY (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101390 · Qualigen, Inc. · Chemistry device
Aug 2010
Decision
88d
Days
Class 2
Risk

K101390 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 August 13, 2010 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K101390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2010
Decision Date August 13, 2010
Days to Decision 88 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 234d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

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

Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K101390.
Atellica® IM TSH3-Ultra II (TSH3ULII)
K251543 · Siemens Healthcare Diagnostics, Inc. · Feb 2026
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
K243570 · Siemens Healthcare Diagnostics · Apr 2025
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
K233050 · Siemens Healthcare Diagnostics, Inc. · Apr 2024
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
K222116 · Siemens Healthcare Diagnostics, Inc. · Jul 2023
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · Beckman Coulter, Inc. · Nov 2022