510(k) · Cleared
Recalled · Class II · 2025Alinity i Total ß-hCG Reagent Kit, Alinity i System
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 Oct 23, 2017 as substantially equivalent to K983424 (Abbott Laboratories, 1998) and 1 other predicate after a 264-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Oct 23, 2017
- Review
- 264 days
- Class
- Class II
- Product code
- DHA
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983212 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK983212 Abbott Architect TestosteroneAbbott Laboratories · 1998 · Recalled
- This deviceK170317 Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories · 2017
- Descendant · cites it directly · 0 of its ownK230790 Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit…Abbott Laboratories · 2023
Most influential descendants
Showing 1 of 1 · See all- K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…Abbott Laboratories · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983212 | Abbott Architect Testosterone | Abbott Laboratories | 1998 | 14 |
| 0 (this device) | K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Abbott Laboratories | 2017 | — |
| +1 | K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c… | Abbott Laboratories | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K983424 | Abbott Archeitect Total B-HCGSummary page 5…c chemistry analyzer for clinical use Governing Regulation: 21 CFR 862.2160 Product Code: JJE III. Predicate Device Reagents ARCHITECT Total β-hCG (k983424) Instrument ARCHITECT i System (k983212) Supplement to k170317 Alinity i Total β-hCG 510(k) October 2017… | 1998 |
| * | K983212 | Abbott Architect TestosteroneSummary page 5…g Regulation: 21 CFR 862.2160 Product Code: JJE III. Predicate Device Reagents ARCHITECT Total β-hCG (k983424) Instrument ARCHITECT i System (k983212) Supplement to k170317 Alinity i Total β-hCG 510(k) October 2017… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample… | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2025 | Class II | Z-0961-2026 | Software design | Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software… |
| Nov 24, 2022 | Class III | Z-0958-2023 | Material/Component Contamination | Reaction vessels may contain a potential contaminant that could affect their optical performance. |
| Nov 21, 2018 | Class II | Z-0666-2019 | Nonconforming Material/Component | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2017, 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?
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.
The Alinity i System is a fully automated immunoassay 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 analyte in samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170317: Alinity i Total ß-hCG Reagent Kit, Alinity i System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170317
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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