Cleared Traditional

K001455 - ACCUWELL TSH, MODEL KAW-TSH-960

K001455 is an FDA 510(k) clearance for ACCUWELL TSH, manufactured by Neometrics, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K001455 · Neometrics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
177d
Days
Class 2
Risk

K001455 is an FDA 510(k) clearance for the ACCUWELL TSH, MODEL KAW-TSH-960. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on November 2, 2000 after a review of 177 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 Neometrics, Inc. devices

FDA 510(k) Submission Details - K001455

510(k) Number K001455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2000
Decision Date November 02, 2000
Days to Decision 177 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 88d · This submission: 177d
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 195
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K001455.
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
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
THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
K990658 · Little Nell Labs, Inc. · Jun 1999