510(k) · Cleared
ClearedValidate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set
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 Jun 25, 2009 as substantially equivalent to K012120 (Maine Standards Co., 2001) after a 59-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- Jun 25, 2009
- Review
- 59 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K863751 (1986). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK863751 Multi-Analyte Lin-TrolSigma Diagnostics, Inc. · 1986
- 1 generation backK012120 Validate Chem 4 Calibration Verification Test Set, Model 10004Maine Standards Co. · 2001
- This deviceK091225 Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity…Maine Standards Co. · 2009
- Descendant · cites it directly · 0 of its ownK153712 VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification…Radiometer America, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…Radiometer America, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863751 | Multi-Analyte Lin-Trol | Sigma Diagnostics, Inc. | 1986 | — |
| −1 | K012120 | Validate Chem 4 Calibration Verification Test Set, Model 10004 | Maine Standards Co. | 2001 | — |
| 0 (this device) | K091225 | Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set | Maine Standards Co. | 2009 | — |
| +1 | K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7… | Radiometer America, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (7)
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 |
|---|---|---|---|
| * | K012120 | Validate Chem 4 Calibration Verification Test Set, Model 10004Summary page 1…e Standards Company, Windham, ME. - VALIDATE® Chem 7 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME. **Note: The VALIDATE® CHEM 4 K012120 that was filed contained the following analytes: ALT, AST, CK, LD, ALP, AMY, GGT, LIP, TBIL, and DBIL. Later, the TBIL and DBIL… | 2001 |
| * | — | VALIDATE® Chem 1 Calibration Verification / Linearity Test Set Named without a submission number | |
| * | — | VALIDATE® Chem 2 Calibration Verification / Linearity Test Set Named without a submission number | |
| * | — | VALIDATE® Chem 3 Calibration Verification / Linearity Test Set Named without a submission number | |
| * | — | VALIDATE® Chem 5 Calibration Verification / Linearity Test Set Named without a submission number | |
| * | — | VALIDATE® Chem 6 Calibration Verification / Linearity Test Set Named without a submission number | |
| * | — | VALIDATE® Chem 7 Calibration Verification / Linearity Test Set Named without a submission number |
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 |
|---|---|---|---|
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification… | 2016 | 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 23 years and passes through 2 companies; a new generation was cleared every 14.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K153712 (Radiometer America, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K012120.
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?
Validate® GC Calibration Verification / Linearity Test Sets 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. See attached Package Insert labeling for all analytes claimed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091225 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091225: Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091225
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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