Cleared Traditional

K223690 - iFlash-HCG

Also marketed or referenced as:
Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

K223690 is an FDA 510(k) clearance for iFlash-HCG, manufactured by Shenzhen Yhlo Biotech Co., Ltd.. The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 367-day FDA review.

K223690 · Shenzhen Yhlo Biotech Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
367d
Days
Class 2
Risk

K223690 is an FDA 510(k) clearance for the iFlash-HCG. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Shenzhen Yhlo Biotech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 11, 2023 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Shenzhen Yhlo Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K223690

510(k) Number K223690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2022
Decision Date December 11, 2023
Days to Decision 367 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 88d · This submission: 367d
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
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K223690.
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
K233581 · Ortho-Clinical Diagnostics · May 2024
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
K230937 · Abbott Laboratories · Jun 2023
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
K230790 · Abbott Laboratories · May 2023
Access Total ßhCG (5th IS)
K221990 · Beckman Coulter, Inc. · Dec 2022
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
K212221 · Diazyme Laboratories, Inc. · Dec 2021
Elecsys HCG STAT
K203227 · Roche Diagnostics · Aug 2021