# K103364: Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: May 6, 2011 after 171 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: 1 generation back to K093492 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093492: Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical Calibrator, Diamond Diagnostics, Inc. (2010) Summary page 2.

## Most influential descendants
- K124009: Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed Chemistry Controls Level 2, Mission C (2013), 0 descendants of its own

## 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, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha Hydroxybutyrate Dehydrogenase4 (o-HBDH), Amyiase, Apolipoprotein A-1, Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement, C4 Complement, Calcium, Carbon Dioxide (C02), Chloride, Cholesterol (Total), HDL-Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (OK), Creatinine, Gamma Glutamnyltransferase (GGT), Glucose, immunoglobulin A (IgA), Immunoglobulin G (lgG), Immunoglobulin M (IgM), 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/K103364
Methodology: https://510kreport.com/methodology