510(k) · Cleared
ClearedAccess Total BHCG (5TH IS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Oct 1, 2013 as substantially equivalent to K925277 (Ciba Corning Diagnostics Corp., 1993) after a 271-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Oct 1, 2013
- Review
- 271 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925277 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK925277 Ciba Corning Acs HCG ImmunoassayCiba Corning Diagnostics Corp. · 1993
- This deviceK130020 Access Total BHCG (5TH IS)Beckman Coulter, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK221990 Access Total ßhCG (5th IS)Beckman Coulter, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK192547 Maglumi 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925277 | Ciba Corning Acs HCG Immunoassay | Ciba Corning Diagnostics Corp. | 1993 | — |
| 0 (this device) | K130020 | Access Total BHCG (5TH IS) | Beckman Coulter, Inc. | 2013 | — |
| +1 | K221990 | Access Total ßhCG (5th IS) | Beckman Coulter, Inc. | 2022 | — |
| +1 | K192547 | Maglumi 2000 HCG/ß-HCG | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K925277 | Ciba Corning Acs HCG ImmunoassaySummary page 1…(21 CFR 862.1155) Secondary Calibrator (21CFR 862.1150) Predicate Device ADVIA Centaur Total hCG Assay (k925277) Manufactured by Siemens Healthcare Diagnostics, Inc. Device Description The Access Total PhCG (5 th IS) as… | 1993 |
What descends from it? (2)
2 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?
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. 2013, 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 Access Total [IhCG (5h IS)assay is aparamagnetic particle, chemi luminescent
immunoassay for the quantitative determination of total PhCG levels in human serum and
plasma using the Access Inmmunoassay Systems. The assay is intended for use as an aid
in the early detection of pregnancy.
The Access Total PhCG (5th IS)calibrators air intended to calibrate the Access Total
PhCG (5h' IS) assay for the quantitative determination of total IPhCG levels in human
serum and plasma using the Access Immunoassay Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130020: Access Total BHCG (5TH IS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130020
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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