510(k) · Cleared
ClearedValidate Ferritin 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 · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Feb 5, 2014 as substantially equivalent to K013119 (Maine Standards Co., 2001) after a 78-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Feb 5, 2014
- Review
- 78 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K893139 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK893139 Document (TM) Uric Acid Linearity Test SetCasco Standards · 1989
- 1 generation backK013119 Validate Chem 6 Calibration Verification Test Set Model # 10006Maine Standards Co. · 2001
- This deviceK133550 Validate Ferritin Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2014
- Descendant · cites it directly · 0 of its ownK142964 VALIDATE Anemia Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2015
Most influential descendants
Showing 1 of 1 · See all- K142964VALIDATE Anemia Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K893139 | Document (TM) Uric Acid Linearity Test Set | Casco Standards | 1989 | — |
| −1 | K013119 | Validate Chem 6 Calibration Verification Test Set Model # 10006 | Maine Standards Co. | 2001 | — |
| 0 (this device) | K133550 | Validate Ferritin Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2014 | — |
| +1 | K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (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 |
|---|---|---|---|
| * | K013119 | Validate Chem 6 Calibration Verification Test Set Model # 10006Summary page 1…edicate Device ldentification: 'VALIDATE® Chem 6:Calibration Verification:/:Linearity Test Kit Maine Standards Company LLC, Cumbertand Foreside, ME:04110. 510(k) Number K013119. D..Candidate Device:description: Each VALIDATE® FERRITIN: Cahbratlon Verification:/. Lmeanty Test Kit'contains: punfled chemical… | 2001 |
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 |
|---|---|---|---|
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | 2015 | 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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142964 (Maine Standards Company, LLC, 2015) has gone furthest, with 0 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. 2014, this device’s year, is highlighted.
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?
VALIDATE® FERRITIN 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 analyte, ferritin, 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/K133550 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133550: Validate Ferritin Calibration Verification/ Linearity Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133550
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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