510(k) · Cleared
ClearedArchitect Free Psa Mastercheck, Model 6C07-05; Architect Tital Psa Mastercheck, Model 6C06-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Sep 17, 2004 as substantially equivalent to K990393 (Bio-Rad, 1999) after an 18-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Sep 17, 2004
- Review
- 18 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950469 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
- 1 generation backK990393 Architect Progesterone Mastercheck Model #6C26-05Bio-Rad · 1999
- This deviceK042335 Architect Free Psa Mastercheck, Model 6C07-05; Architect Tital Psa…Bio-Rad Laboratories, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | 1995 | — |
| −1 | K990393 | Architect Progesterone Mastercheck Model #6C26-05 | Bio-Rad | 1999 | — |
| 0 (this device) | K042335 | Architect Free Psa Mastercheck, Model 6C07-05; Architect Tital Psa… | Bio-Rad Laboratories, Inc. | 2004 | — |
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 JJY? 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 |
|---|---|---|---|
| * | K990393 | Architect Progesterone Mastercheck Model #6C26-05Summary page 4…stantial Equivalence is Claimed Architect Progesterone MasterCheck Abbott Laboratories Abbott Park, IL60064 510 (k) Number: K990393 4.0 Description of Device These are liquid products prepared from HEPES buffer with protein (bovine), consti… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Free PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Free PSA assay on the Abbott ARCHITECT | System.
Total PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Total PSA assay on the Abbott ARCHITECT { 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/K042335 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042335: Architect Free Psa Mastercheck, Model 6C07-05; Architect Tital Psa Mastercheck, Model 6C06-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042335
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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