Cleared Traditional

K234091 - Maverick Diagnostic System TC1000

Also marketed or referenced as:
Maverick Test Panel A0.B0

K234091 is an FDA 510(k) clearance for Maverick Diagnostic System TC1000, manufactured by Genalyte, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K234091 · Genalyte, Inc. · Chemistry device
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Jul 2024
Decision
209d
Days
Class 2
Risk

K234091 is an FDA 510(k) clearance for the Maverick Diagnostic System TC1000. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Genalyte, Inc. (San Diego, US). The FDA issued a Cleared decision on July 22, 2024 after a review of 209 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 Genalyte, Inc. devices

FDA 510(k) Submission Details - K234091

510(k) Number K234091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2023
Decision Date July 22, 2024
Days to Decision 209 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
121d slower than avg
Panel avg: 88d · This submission: 209d
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 164
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K234091.
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K190773 · Roche Diagnostics · Apr 2019