510(k) · Cleared
Recalled · 2010Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Mar 18, 1998 after a 57-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 18, 1998
- Review
- 57 days
- Class
- Class II
- Product code
- JHI
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK980173 Access Total BHCG Reagents on the Access Immunoassay Analyzer…Beckman Instruments, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK023480 Access Total BHCGBeckman Coulter, Inc. · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K023480Access Total BHCGBeckman Coulter, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505 | Beckman Instruments, Inc. | 1998 | — |
| +1 | K023480 | Access Total BHCG | Beckman Coulter, Inc. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 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 |
|---|---|---|---|
| * | — | ACS:180 Total hCG B+ Named without a submission number |
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 |
|---|---|---|---|
| K023480 | Access Total BHCG | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2010 | Not classified | Z-1736-2011 | Pending | Beckman Coulter has confirmed that non-reproducible falsely elevated test results may occur when using the Access Total BhCG assay. These elevated results are often attributed to pre-analytical factors and are particularly noted at the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023480 (Beckman Coulter, Inc., 2002) has gone furthest, with 0 descendants of its own.
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 BhCG assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of total BhCG in human serum, using the the ACCESS® Immunoassay System.
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/K980173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980173: Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980173
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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