510(k) · Cleared
ClearedMission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed Chemistry Controls Level 2, Mission C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Diagnostics, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Apr 17, 2013 as substantially equivalent to K103364 (Diamond Diagnostics, Inc., 2011) after a 111-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- Apr 17, 2013
- Review
- 111 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K093492 (2010). No later device cites it as a predicate yet.
- Root · 2 generations backK093492 Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission…Diamond Diagnostics, Inc. · 2010
- 1 generation backK103364 Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2…Diamond Diagnostics, Inc. · 2011
- This deviceK124009 Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission…Diamond Diagnostics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K093492 | Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical… | Diamond Diagnostics, Inc. | 2010 | — |
| −1 | K103364 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level | Diamond Diagnostics, Inc. | 2011 | — |
| 0 (this device) | K124009 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck… | Diamond Diagnostics, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K103364 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual LevelSummary page 2…rify values before accepting new ranges. Predicate Device: Mission CliniCheck Assayed Chemistry Control, Levels 1and 2 Predicate 510(k): K103364 Page 2 of 4 ===… | 2011 |
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 3 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- None of the 2 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. 2013, 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?
Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes: Acetaminophen, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha- I Anti-Trypsin, Alpha Fetoprotein, Alpha Hydroxybutyrate Dehydrogenase (a-HBDH), Amylase, Apolipoprotein A- I (APO-A 1), Aspartate Aminotransferase (AST/GOT)…
Read the full statement (148 words)
Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes: Acetaminophen, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha- I Anti-Trypsin, Alpha Fetoprotein, Alpha Hydroxybutyrate Dehydrogenase (a-HBDH), Amylase, Apolipoprotein A- I (APO-A 1), Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement, C4 Complement, Calcium, Carbon Dioxide (C02), Carcinoembryonic Antigen (CEA), Ceruloplasmin, Chloride, Cholesterol (Total), HDL- Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Digoxin, Gamma Glutamyltransferase (GGT). Glucose, Haptoglobin, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (1gM), Iron, Iron-Binding Capacity, Total (TIBC), Iron-Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein- Total, Salicylate, Sodium, T3 Free, T3 Total, T4 Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea, Urea Nitrogen, and Uric Acid on instruments listed in the expected values chart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124009: Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed Chemistry Controls Level 2, Mission C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124009
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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