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
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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.

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 225
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K001455.
PRAXSYS RELIA TSH TEST
K011527 · Praxsys Biosystems, Inc. · Aug 2001
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)
K011525 · Biosafe Laboratories, Inc. · Jul 2001
BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)
K003752 · Biosafe Laboratories, Inc. · Mar 2001
REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
K001606 · Repromedix Corp. · Oct 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
K001455 · ACCUWELL TSH, MODEL KAW-TSH-960
Download PDF Neometrics, Inc.