510(k) · Cleared
ClearedAccess Hybritech Free Psa QC, Model 37219
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jan 5, 2000 after a 103-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Jan 5, 2000
- Review
- 103 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK993210 Access Hybritech Free Psa QC, Model 37219Beckman Coulter, Inc. · 2000
- Descendant · cites it directly · 4 of its ownK112603 Access Hybritech P2PSA QC on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK131536 Immulite 2000 Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK122534 Immulite 1000 Third Generation Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK133816 Immulite 2000 Free Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK132739 Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K112603Access Hybritech P2PSA QC on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2011 · cites it directly4descendants
- K131536Immulite 2000 Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013 · 2 generations on1descendant
- K122534Immulite 1000 Third Generation Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013 · 2 generations on1descendant
- K133816Immulite 2000 Free Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on0descendants
- K132739Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993210 | Access Hybritech Free Psa QC, Model 37219 | Beckman Coulter, Inc. | 2000 | — |
| +1 | K112603 | Access Hybritech P2PSA QC on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2011 | — |
| +2 | K131536 | Immulite 2000 Psa Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +2 | K122534 | Immulite 1000 Third Generation Psa Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +3 | K133816 | Immulite 2000 Free Psa Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +3 | K132739 | Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 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 JJX? 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?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112603 | Access Hybritech P2PSA QC on the Access Immunoassay Systems | 2011 | 4 |
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, K112603 (Beckman Coulter, Inc., 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACCESsS® Hybritech® free PSA QC are bi-level controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free PSA using the Access® Immunoassay Systems.
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/K993210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993210: Access Hybritech Free Psa QC, Model 37219.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993210
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