510(k) · Cleared
Recalled · Class II · 2024Trademark Blood Gas/Electrolyte/Glucose, Lactate, Bun and Creatinine Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionostics, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Aug 28, 1997 after a 24-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 28, 1997
- Review
- 24 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK972868 Trademark Blood Gas/Electrolyte/Glucose, Lactate, Bun and Creatinine…Bionostics, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK012431 Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi…Bionostics, Inc. · 2001
Most influential descendants
Showing 1 of 1 · See all- K012431Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control…Bionostics, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972868 | Trademark Blood Gas/Electrolyte/Glucose, Lactate, Bun and Creatinine Control | Bionostics, Inc. | 1997 | — |
| +1 | K012431 | Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte… | Bionostics, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K012431 | Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control… | 2001 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2024 | Class II | Z-1315-2024 | Storage | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60… |
| Jan 9, 2024 | Class II | Z-1314-2024 | Storage | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012431 (Bionostics, Inc., 2001) has gone furthest, with 0 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?
This material is intended for use to monitor the measurements of: a. pH and pCO2 and p02 in blood gas analyzers, b. Na, K, C1, Li, Cat+, and Mg++ in electrolyte analyzers, and; c. glucose, lactate, BUN and creatinine in analyzers which measure these metabolites. The Control is provided at three clinically significant levels to make possible verification of instrument performance at different points for each analyte. This product is for In Vitro…
Read the full statement (165 words)
This material is intended for use to monitor the measurements of:
a. pH and pCO2 and p02 in blood gas analyzers,
b. Na, K, C1, Li, Cat+, and Mg++ in electrolyte analyzers, and;
c. glucose, lactate, BUN and creatinine in analyzers which measure these metabolites.
The Control is provided at three clinically significant levels to make possible verification of instrument performance at different points for each analyte.
This product is for In Vitro Diagnostic Use only.
Determination of acid-base status, and the concentrations of oxygen, carbon dioxide, electrolytes and certain critical metabolites in arterial blood is an important adjust to patient monitoring for a variety of clinical conditions.
Since therapeutic regiments are often determined by the results obtained on patient samples, the instruments used to perform these measurements must meet stringent requirements for accuracy and precision. The use of this quality control material is to confirm the performance of instruments which measure critical blood analytes (i.e. electrolytes and critical metabolites) and blood gases and pH.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972868 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972868: Trademark Blood Gas/Electrolyte/Glucose, Lactate, Bun and Creatinine Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972868
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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