510(k) · Cleared
ClearedAtellica IM Total hCG (ThCG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Mar 29, 2018 as substantially equivalent to K925277 (Ciba Corning Diagnostics Corp., 1993) after a 240-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Mar 29, 2018
- Review
- 240 days
- Class
- Class II
- Product code
- JHI
- 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 deviceK172322 Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK200210 ADVIA Centaur® Total hCG assaySiemens Healthcare Diagnostics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK192790 Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. · 2019
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) | K172322 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2018 | — |
| +1 | K200210 | ADVIA Centaur® Total hCG assay | Siemens Healthcare Diagnostics, Inc. | 2021 | — |
| +1 | K192790 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K925277 | Ciba Corning Acs HCG ImmunoassaySummary page 4…gulation Section: 21 CFR § 862.1155 Product Code: JHI Panel: Clinical Chemistry III. PREDICATE DEVICE Assay Name of Device: ADVIA Centaur® Total hCG assay 510 (k): k925277 Siemens Healthcare Diagnostics Inc. Section 005 -1… | 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 JHI devicesJHI Visual, Pregnancy Hcg, Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 Atellica IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica IM Analyzer.
The Atellica IM ThCG assay is intended for use as an aid in 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/K172322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172322: Atellica IM Total hCG (ThCG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172322
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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