510(k) · Cleared
ClearedVK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer America, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jan 28, 2016 as substantially equivalent to K091225 (Maine Standards Co., 2009) after a 35-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jan 28, 2016
- Review
- 35 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K863751 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK863751 Multi-Analyte Lin-TrolSigma Diagnostics, Inc. · 1986
- 2 generations backK012120 Validate Chem 4 Calibration Verification Test Set, Model 10004Maine Standards Co. · 2001
- 1 generation backK091225 Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity…Maine Standards Co. · 2009
- This deviceK153712 VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification…Radiometer America, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863751 | Multi-Analyte Lin-Trol | Sigma Diagnostics, Inc. | 1986 | — |
| −2 | K012120 | Validate Chem 4 Calibration Verification Test Set, Model 10004 | Maine Standards Co. | 2001 | — |
| −1 | K091225 | Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set | Maine Standards Co. | 2009 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K091225 | Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test SetSummary page 8…Section 5, Page 4 of 13 5 Predicate device Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Sets (K091225) 6 Substantial Equivalence All five Verification Kits are substantially equivalent in intended use, fundamental scientific tech… | 2009 |
| † | K150226 | Hematocrit and Metabolite QUALICHECK | 2015 |
| † | K130236 | Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3 | 2013 |
| † | K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760 | 1998 |
| † | K130415 | High Metabolite Qualicheck | 2013 |
| † | K051928 | AUTOCHECK6+ | 2005 |
| † | K051968 | ABL8X7 Flex | 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 30 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 5 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. 2016, 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?
For in vitro diagnostic use. Verification Kits VK-3, VK-4, VK-RS, VK-R7 and VK-Crea are assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges.
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/K153712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153712: VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153712
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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