510(k) · Cleared
ClearedValidate Thyroid Calibration Verification Test Set, Model 901
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 Mar 23, 2009 as substantially equivalent to K062501 (Maine Standards Co., 2006) after an 84-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Mar 23, 2009
- Review
- 84 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950469 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
- 2 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
- 1 generation backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
- This deviceK083891 Validate Thyroid Calibration Verification Test Set, Model 901Maine Standards Co. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | 1995 | — |
| −2 | K992034 | Document Thyroid Cal*Ver | Casco-Nerl Diagnostics Corporation (Maine) | 1999 | — |
| −1 | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 | Maine Standards Co. | 2006 | — |
| 0 (this device) | K083891 | Validate Thyroid Calibration Verification Test Set, Model 901 | Maine Standards Co. | 2009 | — |
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 |
|---|---|---|---|
| * | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901Summary page 1…21 CFR 862.1660 Product Code: JJY Regulatory Class: Class I Predicate Device: VALIDATEO=TH'fCalibration Verification Test Set (K062501), Maine Standards Company Windham, Maine Device description: VALIDATE®JjffY:3I~aibration Verification Test Sets are human serum… | 2006 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K062501.
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. 2009, 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?
Each VALIDATE® THY Calibration Verification / Linearity Test Set consists of two sets of bottles, a THY Set and a FT4 Set. The THY set consists of five (5) levels of the following four analytes: triiodothyronine (T3), thyroxine (T4), human thyroid stimulating hormone (TSH), and cortisol, and the FT4 set consists of five (5) levels containing Free T4.
VALIDATE® THY Calibration Verification / Linearity 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083891: Validate Thyroid Calibration Verification Test Set, Model 901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083891
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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