Cleared Traditional

K243462 - Diazyme Colorimetric Lithium Assay (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.