510(k) · Cleared
ClearedVALIDATE Anemia Calibration Verification/ Linearity Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maine Standards Company, LLC · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Apr 30, 2015 as substantially equivalent to K133550 (Maine Standards Company, LLC, 2014) after a 198-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Apr 30, 2015
- Review
- 198 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K893139 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK893139 Document (TM) Uric Acid Linearity Test SetCasco Standards · 1989
- 2 generations backK013119 Validate Chem 6 Calibration Verification Test Set Model # 10006Maine Standards Co. · 2001
- 1 generation backK133550 Validate Ferritin Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2014
- This deviceK142964 VALIDATE Anemia Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K893139 | Document (TM) Uric Acid Linearity Test Set | Casco Standards | 1989 | — |
| −2 | K013119 | Validate Chem 6 Calibration Verification Test Set Model # 10006 | Maine Standards Co. | 2001 | — |
| −1 | K133550 | Validate Ferritin Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2014 | — |
| 0 (this device) | K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2015 | — |
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 |
|---|---|---|---|
| * | K133550 | Validate Ferritin Calibration Verification/ Linearity Test KitSummary page 4…icate Device Identification: VALIDATE® Ferritin Calibration Verification / Linearity Test Kit Maine Standards Company LLC, Cumberland Foreside, ME 04110. 510(k) Number: k133550 D. Candidate Device description: Each VALIDATE® Anemia Calibration Verification / Linearity Test Kit contains two analyte sets o… | 2014 |
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 26 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- None of the 3 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. 2015, 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® Anemia Calibration Verification/Linearity Test Kit solutions are intended for in vitro diagnostic use in the
quantitative determination of linearity, calibration verification and verification of reportable range for the following
analytes: Ferritin Set: ferritin (FERR), Vitamin B12 / Folate Set: vitamin B12(VITB) and folate (FOL), on automated
instrument systems. The product is intended for use with quantitative assays on the indicated analyzers specified in the
labeling.
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/K142964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K142964: VALIDATE Anemia Calibration Verification/ Linearity Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K142964
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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