Cleared Traditional

K003752 - BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)

K003752 is an FDA 510(k) clearance for BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTE..., manufactured by Biosafe Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K003752 · Biosafe Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
108d
Days
Class 2
Risk

K003752 is an FDA 510(k) clearance for the BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORM.... Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Biosafe Laboratories, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 23, 2001 after a review of 108 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 Biosafe Laboratories, Inc. devices

FDA 510(k) Submission Details - K003752

510(k) Number K003752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2000
Decision Date March 23, 2001
Days to Decision 108 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
20d slower than avg
Panel avg: 88d · This submission: 108d
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 K003752.
TSH-CTK-3 IRMA
K041014 · DiaSorin, Inc. · Jul 2004
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · Beckman Coulter, Inc. · Nov 2002
CHEMWELL, ALSO KNOWN AS PROJECT 2900
K013420 · Awareness Technology, Inc. · Jul 2002
ACCUWELL TSH, MODEL KAW-TSH-960
K001455 · Neometrics, Inc. · Nov 2000
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT
K990993 · Biocheck, Inc. · Jun 1999
TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
K991146 · Biocheck, Inc. · Jun 1999