510(k) · Cleared
ClearedChem-Chex Stat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck Laboratories, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on May 15, 1996 as substantially equivalent to K934641 (I-Stat Corp., 1993) after a 49-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- May 15, 1996
- Review
- 49 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934641 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK934641 I-Stat Control Levels 1,2,3I-Stat Corp. · 1993
- This deviceK961195 Chem-Chex StatStreck Laboratories, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK993321 R&D HGB/GLC Whole Blood ControlR&D Systems, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK034048 R&D Glu-Line Hematology ControlR&D Systems, Inc. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934641 | I-Stat Control Levels 1,2,3 | I-Stat Corp. | 1993 | — |
| 0 (this device) | K961195 | Chem-Chex Stat | Streck Laboratories, Inc. | 1996 | — |
| +1 | K993321 | R&D HGB/GLC Whole Blood Control | R&D Systems, Inc. | 1999 | — |
| +2 | K034048 | R&D Glu-Line Hematology Control | R&D Systems, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K934641 | I-Stat Control Levels 1,2,3Summary page 1…m-Chex STAT Com/non Name: Assayed chemistry control Classification Name: Multi-analyte control (§862.1660) Classification Number: 75JJY Predicate Device: i-STAT control (K934641) manufactured for i-STAT Corp. Description: Chem-Chex STAT is a suspension of stabilized human red biood cells in an aqueous buf… | 1993 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993321 | R&D HGB/GLC Whole Blood Control | 1999 | 1 |
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?
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?
Chem-Chex STAT is intended to be used for verifying the accuracy of i-STAT chemistry analyzers used with 6+ test cartridges. Chem-Chex STAT is assayed for Na+ Cl- K+ BUN, Hgb, Hct, and Glucose.
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/K961195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961195: Chem-Chex Stat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961195
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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