510(k) · Cleared
ClearedAlinity i Total ß-hCG Reagent Kit, GLP systems Track
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Jun 5, 2023 as substantially equivalent to K213486 (Abbott Laboratories, 2022) after a 63-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Jun 5, 2023
- Review
- 63 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K902336 (1990). 11 ancestors in all, the oldest K872494 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 6 generations backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- 5 generations backK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- 4 generations backK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
- 3 generations backK082638 Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · Recalled
- 2 generations backK093318 Accelerator ApsAbbott Laboratories · 2010 · Recalled
- 1 generation backK213486 GLP systems TrackAbbott Laboratories · 2022
- This deviceK230937 Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −6 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| −5 | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −4 | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | 8 |
| −3 | K082638 | Advia Centaur System with Streamlab Analytical Workcell | Siemens Healthcare Diagnostics, Inc. | 2009 | 3 |
| −2 | K093318 | Accelerator Aps | Abbott Laboratories | 2010 | 2 |
| −1 | K213486 | GLP systems Track | Abbott Laboratories | 2022 | — |
| 0 (this device) | K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Laboratories | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 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? (1)
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 |
|---|---|---|---|
| * | K213486 | GLP systems TrackSummary page 6…lassification Name: Human chorionic gonadotropin (HCG) test system Governing Regulation: 862.1155 Product Code: DHA IV. Predicate Device GLP systems Track (K213486) V. Device Description A. GLP systems Track The GLP systems Track is a modular laboratory automation system (LAS) u… | 2022 |
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 33 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 6 of the 11 ancestors have a recall of any class.
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?
GLP systems Track: The GLP systems Track is a modular laboratory automation system designed to automate pre-analytical and post-analytical processing, including sample handling, in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow. Alinity i Total β-hCG Reagent Kit: The Alinity i Total β-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the…
Read the full statement (280 words)
GLP systems Track:
The GLP systems Track is a modular laboratory automation system designed to automate pre-analytical and post-analytical processing, including sample handling, in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow.
Alinity i Total β-hCG Reagent Kit:
The Alinity i Total β-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (β-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.
Alinity i system:
The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
Alinity ci-series:
The Alinity ci-series is intended for in vitro diagnostic use only.
The Alinity ci-series is a System comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation.
The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.
The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230937: Alinity i Total ß-hCG Reagent Kit, GLP systems Track.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230937
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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