510(k) · Cleared
Recalled · 2009Access Total BHCG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Dec 20, 2002 as substantially equivalent to K980173 (Beckman Instruments, Inc., 1998) after a 64-day review. Its family tree reaches back 1 generation to 1998. It has been recalled once.
- Decided
- Dec 20, 2002
- Review
- 64 days
- Class
- Class II
- Product code
- JHI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980173 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980173 Access Total BHCG Reagents on the Access Immunoassay Analyzer…Beckman Instruments, Inc. · 1998 · Recalled
- This deviceK023480 Access Total BHCGBeckman Coulter, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505 | Beckman Instruments, Inc. | 1998 | 1 |
| 0 (this device) | K023480 | Access Total BHCG | Beckman Coulter, Inc. | 2002 | — |
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 JHI? 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 JHI device
- #1 K262299 Instant-View® hCG Combo II Cassette Testscore 12.7 · 3 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 |
|---|---|---|---|
| * | K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Summary page 1…ccess Immunoassay Systems. Substantial Equivalence Comparison The Access Total PhCG assay is substantially equivalent to the previously cleared Access Total PhCG assay (K980173). Both assays utilize the same methodology, are the same product type, and are quantitative. The subject and predicate assays inc… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2009 | Not classified | Z-0050-2012 | Nonconforming Material/Component | The recall was initiated because Beckman Coulter has confirmed that certain Access Total hCG reagent packs show decreased stability from the date of manufacture, which may lead to increased imprecision. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All JHI devicesJHI Visual, Pregnancy Hcg, Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHI
101in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JHI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHI
265in 2025
MAUDE reports naming product code JHI, 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 | 4 | 101 | 6 | 245 |
| 2008 | 0 | — | 8 | 29 |
| 2009 | 0 | — | 1 | 106 |
| 2010 | 1 | — | 2 | 143 |
| 2011 | 0 | — | 1 | 138 |
| 2012 | 2 | — | 0 | 219 |
| 2013 | 2 | — | 0 | 185 |
| 2014 | 2 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 134 |
| 2016 | 1 | — | 0 | 143 |
| 2017 | 1 | — | 0 | 113 |
| 2018 | 1 | — | 0 | 132 |
| 2019 | 0 | — | 0 | 571 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 1 | — | 0 | 126 |
| 2023 | 0 | — | 6 | 147 |
| 2024 | 1 | — | 1 | 256 |
| 2025 | 0 | — | 0 | 265 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The Access Total PhCG assay provides in vitro quantitative determination of total βhCG levels in human serum and plasma. The Access Total PhCG assay is indicated for use with patients where an early detection of pregnancy status is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023480: Access Total BHCG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023480
Report an extraction error
Are you the manufacturer?
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