Cleared Traditional

Diazyme DZ-Lite Total beta-hCG Test System (K163418) - FDA 510(k) Clearance

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

K163418 · Diazyme Laboratories · Chemistry device
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Aug 2017
Decision
255d
Days
Class 2
Risk

K163418 is an FDA 510(k) clearance for the Diazyme DZ-Lite Total beta-hCG Test System. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on August 18, 2017 after a review of 255 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.

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Submission Details

510(k) Number K163418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2016
Decision Date August 18, 2017
Days to Decision 255 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
167d slower than avg
Panel avg: 88d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K163418.
MAGLUMI 2000 HCG/ß-HCG
K192547 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Jan 2020
Atellica IM Total hCG (ThCG)
K192790 · Siemens Healthcare Diagnostics, Inc. · Oct 2019
Alinity i Total ß-hCG Reagent Kit, Alinity i System
K170317 · Abbott Laboratories · Oct 2017
ACCESS TOTAL BHCG (5TH IS)
K130020 · Beckman Coulter, Inc. · Oct 2013
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
K063754 · Dade Behring, Inc. · Feb 2007
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
K060548 · Dade Behring, Inc. · Apr 2006