510(k) · Cleared
ClearedHuman Chorionic Gonadotropin Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Chemistry Systems, Inc. · JIW Calibrator, Surrogate
Cleared on Feb 20, 1997 after a 17-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 20, 1997
- Review
- 17 days
- Class
- Class II
- Product code
- JIW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970396 Human Chorionic Gonadotropin CalibratorDade Chemistry Systems, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK063754 Dimension Vista (TM) BHCG Flex (R) Reagent Cartridge, and BHCG…Dade Behring, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063754Dimension Vista (TM) BHCG Flex (R) Reagent Cartridge, and BHCG Calibrator, Model#…Dade Behring, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970396 | Human Chorionic Gonadotropin Calibrator | Dade Chemistry Systems, Inc. | 1997 | — |
| +1 | K063754 | Dimension Vista (TM) BHCG Flex (R) Reagent Cartridge, and BHCG Calibrator… | Dade Behring, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 JIW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | aca® plus Human Chorionic Gonadotropin Calibrator 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 |
|---|---|---|---|
| K063754 | Dimension Vista (TM) BHCG Flex (R) Reagent Cartridge, and BHCG Calibrator, Model#… | 2007 | 0 |
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, K063754 (Dade Behring, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIW devicesJIW Calibrator, Surrogate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIW
FDA has decided no JIW device since 2007.
Median 510(k) review, days · JIW
Too few JIW 510(k)s in any year since 2007 to give a median.
Recalls per year · JIW
No recall names JIW since 2007.
Adverse event reports per year · JIW
No MAUDE report names JIW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HCG Calibrator is intended to be used to calibrate the HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
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/K970396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970396: Human Chorionic Gonadotropin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970396
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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