Cleared Traditional

K243462 - Diazyme Colorimetric Lithium Assay

K243462 is an FDA 510(k) clearance for Diazyme Colorimetric Lithium Assay, manufactured by Diazyme Laboratories, Inc.. The device is a Class 2 Chemistry device with product code NDW cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K243462 · Diazyme Laboratories, Inc. · Chemistry device
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Aug 2025
Decision
266d
Days
Class 2
Risk

K243462 is an FDA 510(k) clearance for the Diazyme Colorimetric Lithium Assay. Classified as Assay, Porphyrin, Spectrophotometry, Lithium (product code NDW), Class II - Special Controls.

Submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on August 1, 2025 after a review of 266 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3560 - 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 Diazyme Laboratories, Inc. devices

FDA 510(k) Submission Details - K243462

510(k) Number K243462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2024
Decision Date August 01, 2025
Days to Decision 266 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
178d slower than avg
Panel avg: 88d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDW Device Classification - Class 2, Special Controls

Product Code NDW Assay, Porphyrin, Spectrophotometry, Lithium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3560
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.