# K124009: Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed Chemistry Controls Level 2, Mission C

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Apr 17, 2013 after 111 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K093492 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103364: Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level, Diamond Diagnostics, Inc. (2011) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K124009
Methodology: https://510kreport.com/methodology