510(k) · Cleared
ClearediFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Yhlo Biotech Co., Ltd. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Dec 11, 2023 as substantially equivalent to K003178 (Roche Diagnostics Corp., 2000) and 1 other predicate after a 367-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Dec 11, 2023
- Review
- 367 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915195 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK915195 Enzymun-Test TSHBoehringer Mannheim Corp. · 1992
- 2 generations backK961491 Elecsys TSH AssayBoehringer Mannheim Corp. · 1996
- 1 generation backK162606 Elecsys TSH assay, cobas e 801 Immunoassay analyzerRoche Diagnostics · 2017 · Recalled
- This deviceK223690 iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash…Shenzhen Yhlo Biotech Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915195 | Enzymun-Test TSH | Boehringer Mannheim Corp. | 1992 | — |
| −2 | K961491 | Elecsys TSH Assay | Boehringer Mannheim Corp. | 1996 | — |
| −1 | K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Roche Diagnostics | 2017 | 3 |
| 0 (this device) | K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | Shenzhen Yhlo Biotech Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DHA device
- #1 K233581 VITROS Immunodiagnostic Products Total ß-hCG…score 7.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003178 | Elecsys HCG and Beta Test SystemSummary page 5…, Test, Human Chorionic Gonadotropin; Analyzer, Chemistry (Photometric, Discrete) for Clinical Use Candidate Device k223690 Predicate Devices k003178, Elecsys HCG+β reagent; k162606, Cobas e 801 analyzer 1 Device Description iFlash-HCG that includes tes… | 2000 |
| * | K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzerSummary page 5…Analyzer, Chemistry (Photometric, Discrete) for Clinical Use Candidate Device k223690 Predicate Devices k003178, Elecsys HCG+β reagent; k162606, Cobas e 801 analyzer 1 Device Description iFlash-HCG that includes testing reagents and three levels of calibrators is base… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K003178.
How does its category compare?
All DHA devicesDHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DHA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DHA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHA
234in 2025
MAUDE reports naming product code DHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 64 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 1 | — | 0 | 196 |
| 2010 | 0 | — | 2 | 179 |
| 2011 | 0 | — | 0 | 478 |
| 2012 | 0 | — | 0 | 277 |
| 2013 | 2 | — | 0 | 244 |
| 2014 | 0 | — | 0 | 119 |
| 2015 | 1 | — | 2 | 52 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 0 | — | 1 | 103 |
| 2019 | 1 | — | 0 | 152 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 3 | 289 | 0 | 210 |
| 2022 | 1 | — | 2 | 185 |
| 2023 | 3 | 63 | 0 | 194 |
| 2024 | 1 | — | 0 | 261 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
iFlash-HCG is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative detection of the intact human chorionic gonadotropin (hCG) molecule and the hCG β-subunit (β-hCG) in human serum and plasma using the automated Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). The iFlash-HCG assay is to be used by laboratory professionals as an aid in early detection of pregnancy together with other clinical methods. Chemiluminescence…
Read the full statement (113 words)
iFlash-HCG is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative detection of the intact human chorionic gonadotropin (hCG) molecule and the hCG β-subunit (β-hCG) in human serum and plasma using the automated Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). The iFlash-HCG assay is to be used by laboratory professionals as an aid in early detection of pregnancy together with other clinical methods.
Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative or qualitative determination of analytes in human body fluids taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagents. The Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223690 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223690: iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223690
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026