510(k) · Cleared
ClearedValidate SP1 Calibration Verification/Linearity Test Set, Model 601
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maine Standards Co. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Sep 14, 2007 as substantially equivalent to K031575 (Cliniqa Corporation, 2003) and 1 other predicate after a 32-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Sep 14, 2007
- Review
- 32 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K031575 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK031575 Linical Protein 2 Calibration Verifiers Levels a-E for Olympus AU…Cliniqa Corporation · 2003
- This deviceK072246 Validate SP1 Calibration Verification/Linearity Test Set, Model 601Maine Standards Co. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031575 | Linical Protein 2 Calibration Verifiers Levels a-E for Olympus AU Analyzers | Cliniqa Corporation | 2003 | — |
| 0 (this device) | K072246 | Validate SP1 Calibration Verification/Linearity Test Set, Model 601 | Maine Standards Co. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 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? (2)
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 |
|---|---|---|---|
| * | K031575 | Linical Protein 2 Calibration Verifiers Levels a-E for Olympus AU AnalyzersSummary page 1…21 CFR 862.1660 Product Code: JJy Regulatory Class: Class I Predicate Device: Cliniqa LiniCAL® Calibration Verifier Protein 1 (K031575) and Cliniqa LiniCAL® Calibration Verifier Protein 2 (K031577) Cliniqa, San Marcos, California. Device description: VALIDATE SP1… | 2003 |
| * | K031577 | Linical Protein 2 Calibration Verifiers Levels a-E for Beckman Coulter Array Protein…Summary page 1…Regulatory Class: Class I Predicate Device: Cliniqa LiniCAL® Calibration Verifier Protein 1 (K031575) and Cliniqa LiniCAL® Calibration Verifier Protein 2 (K031577) Cliniqa, San Marcos, California. Device description: VALIDATE SP1 Calibration Verification Test Sets are human serum calibratio… | 2003 |
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?
- 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. 2007, this device’s year, is highlighted.
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?
VALIDATE® SPI Calibration Verification Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual chemistry systems for the following analytes: Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Complement C3 (C3), Complement C4 (C4), al-Antitrypsin (AAT), and Transfernin (TRF).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072246: Validate SP1 Calibration Verification/Linearity Test Set, Model 601.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072246
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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