510(k) · Cleared
ClearedAlinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
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 May 19, 2023 as substantially equivalent to K170317 (Abbott Laboratories, 2017) and 2 other predicates after a 58-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- May 19, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K872494 (1987). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK872494 Hitachi 717 Chemistry AnalyzerBoehringer Mannheim Corp. · 1987
- 2 generations backK980367 Aeroset SystemAbbott Laboratories · 1998 · Recalled
- 1 generation backK170316 Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories · 2017 · Recalled
- This deviceK230790 Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit…Abbott Laboratories · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872494 | Hitachi 717 Chemistry Analyzer | Boehringer Mannheim Corp. | 1987 | — |
| −2 | K980367 | Aeroset System | Abbott Laboratories | 1998 | 34 |
| −1 | K170316 | Alinity C Glucose Reagent Kit, Alinity C System | Abbott Laboratories | 2017 | 1 |
| 0 (this device) | 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 |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2006 | 1 | 0 |
| 2017 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i SystemSummary page 6…de, ion-specific, chloride/potassium/sodium Governing Regulation: 862.1170/862.1600/862.1665 Code: CGZ/CEM/JGS IV. Predicate Device Alinity i System (k170317) Alinity i Total β‑hCG (k170317) Alinity c System (k170316) Alinity c Glucose (k170316) Alinity c ICT Sample… | 2017 |
| * | K170316 | Alinity C Glucose Reagent Kit, Alinity C SystemSummary page 6…on: 862.1170/862.1600/862.1665 Code: CGZ/CEM/JGS IV. Predicate Device Alinity i System (k170317) Alinity i Total β‑hCG (k170317) Alinity c System (k170316) Alinity c Glucose (k170316) Alinity c ICT Sample Diluent (k170320) V. Description of Device Introduction… | 2017 |
| * | K170320 | Alinity c ICT Sample DiluentSummary page 6…Alinity i System (k170317) Alinity i Total β‑hCG (k170317) Alinity c System (k170316) Alinity c Glucose (k170316) Alinity c ICT Sample Diluent (k170320) V. Description of Device Introduction The Alinity i System (k170317) and the Alinity c System (k170316) were de… | 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 36 years and passes through 2 companies; a new generation was cleared every 10.7 years on median.
- 4 of the 9 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?
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…
Read the full statement (364 words)
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.
The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine on the Alinity c analyzer.
Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230790: Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230790
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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