Cleared Traditional

K212221 - Diazyme DZ-Lite iFlash Total beta-hCG Assay

K212221 is an FDA 510(k) clearance for Diazyme DZ-Lite iFlash Total beta-hCG Assay, manufactured by Diazyme Laboratories, Inc.. The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K212221 · Diazyme Laboratories, Inc. · Chemistry device
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Dec 2021
Decision
150d
Days
Class 2
Risk

K212221 is an FDA 510(k) clearance for the Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chem.... Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on December 13, 2021 after a review of 150 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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 - K212221

510(k) Number K212221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2021
Decision Date December 13, 2021
Days to Decision 150 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
62d slower than avg
Panel avg: 88d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHA Device Classification - Class 2, Special Controls

Product Code DHA System, Test, Human Chorionic Gonadotropin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - DHA System, Test, Human Chorionic Gonadotropin

All 45
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