510(k) · Cleared
ClearedValidate Chem 3 Calibration Verification Test Set, Model 10003
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 Aug 20, 2001 as substantially equivalent to K883861 (Casco Standards, 1988) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it.
- Decided
- Aug 20, 2001
- Review
- 45 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883861 (1988). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK883861 Document (TM) Protein/Cholesterol Linearity TestCasco Standards · 1988
- This deviceK012119 Validate Chem 3 Calibration Verification Test Set, Model 10003Maine Standards Co. · 2001
- Descendant · cites it directly · 3 of its ownK022401 PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD…Sd Biosensor · 2017
- Descendant · 3 generations on · 0 of its ownK130295 Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro…Infopia Co, Ltd. · 2013
Most influential descendants
Showing 4 of 4 · See all- K022401PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002 · cites it directly3descendants
- K090405Lipidpro SystemInfopia Co, Ltd. · 2009 · 2 generations on1descendant
- K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor · 2017 · 2 generations on0descendants
- K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883861 | Document (TM) Protein/Cholesterol Linearity Test | Casco Standards | 1988 | — |
| 0 (this device) | K012119 | Validate Chem 3 Calibration Verification Test Set, Model 10003 | Maine Standards Co. | 2001 | — |
| +1 | K022401 | PTS Panels Multi-Chemistry Controls | Polymer Technology Systems, Inc. | 2002 | — |
| +2 | K090405 | Lipidpro System | Infopia Co, Ltd. | 2009 | — |
| +2 | K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT… | Sd Biosensor | 2017 | — |
| +3 | K130295 | Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional… | Infopia Co, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K883861 | Document (TM) Protein/Cholesterol Linearity TestSummary page 1…Test Set Common Name: Calibration Verification Classification Name: Calibrator, Multi-Analyte Predicate Devices: 1. DOCUMENT Total Protein/Albumin/Cholesterol CAL-VER K883861, manufactured by CASCO NERL Diagnostics. 2. DOCUMENT lron/Magnesium/Triglyceride CAL-VER, K893142, manufactured by CASCO NERL Di… | 1988 |
| * | K893142 | Document (TM) Iron, Magnes, Trigly Linear Test SetSummary page 1…dicate Devices: 1. DOCUMENT Total Protein/Albumin/Cholesterol CAL-VER K883861, manufactured by CASCO NERL Diagnostics. 2. DOCUMENT lron/Magnesium/Triglyceride CAL-VER, K893142, manufactured by CASCO NERL Diagnostics. Device description: VALIDATE Chem 3 Calibration Verification Test Set is a liquid, huma… | 1989 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022401 | PTS Panels Multi-Chemistry Controls | 2002 | 3 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K022401 (Polymer Technology Systems, Inc., 2002) has gone furthest, with 3 descendants of its own.
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.
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?
The VALIDATE Chem 3 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: total protein, albumin, cholesterol, and iron.
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/K012119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012119: Validate Chem 3 Calibration Verification Test Set, Model 10003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012119
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026