Cleared Traditional

K001455 - ACCUWELL TSH

K001455 is the FDA 510(k) clearance for ACCUWELL TSH by Neometrics, Inc.. It is a Class 2 Chemistry device (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.

View all Neometrics, Inc. devices

Submission Details

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
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.

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

All 115
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K001455.
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