510(k) · Cleared
ClearedAbbott Archeitect Total B-HCG
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 Dec 1, 1998 after a 63-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Dec 1, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK983424 Abbott Archeitect Total B-HCGAbbott Laboratories · 1998
- Descendant · cites it directly · 1 of its ownK170317 Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK063720 Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack…Ortho-Clinical Diagnostics · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK233581 VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics · 2024
- Descendant · 2 generations on · 0 of its ownK230790 Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit…Abbott Laboratories · 2023
- Descendant · cites it directly · 0 of its ownK133002 i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT…Abbott Point of Care, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories · 2017 · cites it directly1descendant
- K063720Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range VerifiersOrtho-Clinical Diagnostics · 2007 · cites it directly1descendant
- K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics · 2024 · 2 generations on0descendants
- K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…Abbott Laboratories · 2023 · 2 generations on0descendants
- K133002i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG…Abbott Point of Care, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983424 | Abbott Archeitect Total B-HCG | Abbott Laboratories | 1998 | — |
| +1 | K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Abbott Laboratories | 2017 | 3 |
| +1 | K063720 | Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators… | Ortho-Clinical Diagnostics | 2007 | 1 |
| +2 | K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics | 2024 | — |
| +2 | K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c… | Abbott Laboratories | 2023 | — |
| +1 | K133002 | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total… | Abbott Point of Care, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | — | AxSYM Total B-hCG Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K170317 (Abbott Laboratories, 2017) has gone furthest, with 1 descendant of its own.
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.
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?
Abbott ARCHITECT™ Total B-hCG is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma on the Abbott ARCHITECT i System for the early detection of pregnancy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983424: Abbott Archeitect Total B-HCG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983424
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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