510(k) · Cleared
ClearedDocument Ammonia, Ethanol, Lactate Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Casco Standards · JIX Calibrator, Multi-Analyte Mixture
Cleared on Sep 13, 1996 after a 70-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Sep 13, 1996
- Review
- 70 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK962629 Document Ammonia, Ethanol, Lactate CalibratorCasco Standards · 1996
- Descendant · cites it directly · 5 of its ownK012117 Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001
- Descendant · 2 generations on · 3 of its ownK022401 PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD…Sd Biosensor · 2017
- Descendant · 4 generations on · 0 of its ownK130295 Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro…Infopia Co, Ltd. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K012117Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001 · cites it directly5descendants
- K022401PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002 · 2 generations on3descendants
- K090405Lipidpro SystemInfopia Co, Ltd. · 2009 · 3 generations on1descendant
- K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor · 2017 · 3 generations on0descendants
- K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd. · 2013 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962629 | Document Ammonia, Ethanol, Lactate Calibrator | Casco Standards | 1996 | — |
| +1 | K012117 | Validate Chem 1 Calibration Verification Test Set, Model 10001 | Maine Standards Co. | 2001 | — |
| +2 | K022401 | PTS Panels Multi-Chemistry Controls | Polymer Technology Systems, Inc. | 2002 | — |
| +3 | K090405 | Lipidpro System | Infopia Co, Ltd. | 2009 | — |
| +3 | K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT… | Sd Biosensor | 2017 | — |
| +4 | K130295 | Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional… | Infopia Co, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 JIX? 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? (3)
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 |
|---|---|---|---|
| * | — | New England Reagent Laboratory Ammonia Standards Named without a submission number | |
| * | — | Beckman Alcohol Kit Calibrator Named without a submission number | |
| * | — | Beckman CX Multi Calibrator Named without a submission number |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K012117 (Maine Standards Co., 2001) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended for in vitro diagnostic use for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems used for the measurement of ammonia, ethanol, and lactate. DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended to provide for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values included for the various analytical systems on which it was assayed.
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/K962629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962629: Document Ammonia, Ethanol, Lactate Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962629
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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