← Product Code [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY) · K961750 # DOCUMENT CARDIAC ASSAYED CONTROL (K961750) _Casco Standards · JJY · Jul 22, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K961750 ## Device Facts - **Applicant:** Casco Standards - **Product Code:** [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY.md) - **Decision Date:** Jul 22, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies. ## Device Story DOCUMENT® CARDIAC Assayed Control is a human serum-based liquid control product. It contains creatine kinase isoenzymes, lactate dehydrogenase isoenzymes 1 and 2, and myoglobin. Used in clinical laboratories on automated and semi-automated immunochemistry and clinical chemistry systems. Laboratory personnel use the control to assess analytical performance, monitor accuracy and precision, troubleshoot system/reagent issues, and satisfy regulatory inspection requirements for quality control. The device provides a stable, ready-to-use liquid matrix for verifying system performance across three levels (I, II, III). ## Clinical Evidence Bench testing only. Equivalence established by comparing inter-assay precision of the subject device against multiple predicate controls for the specified analytes (CK, CK-MB, LD, myoglobin). Results indicate the device behaves similarly to predicate devices and is suitable for use as a control. ## Technological Characteristics Liquid human serum matrix containing creatine kinase isoenzymes, lactate dehydrogenase isoenzymes 1 and 2, and myoglobin. Provided in three levels (I, II, III) in plastic containers with dropper tips. No dilution required. Stability: 45 days open-vial. ## Regulatory Identification A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. ## Predicate Devices - Dade CK-MB/Myoglobin Immunoassay Control Level 1,2 and 3 (B5200-1, B5200-2, B5200-3) - Abbott IMx STAT CK-MB Controls, L, M, H (7A28-10) - Bio-Rad Unassayed Chemistry Control (Human) Levels 1 and 2 (16030) - Beckman I.D-Zone Liquid CK Isoenzyme Control (667990) - Beckman I.D-Zone Normal LD Isoenzyme Liquid Control (439090) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K961750 JUL 22 1996 Exhibit 21. 510(k) Summary FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY DOCUMENT® CARDIAC Assayed Control, Levels I, II, III 1. Submitted by: CASCO Standards P.O. Box 970 Yarmouth, ME 04096 Attention: Christine V. Beach Manager, Regulatory Affairs (207) 878-7550 (207) 878-7578 FAX May 5, 1996 2. Product Name: Proprietary Name: DOCUMENT® CARDIAC Assayed Control Classification Name: Control, multiple analyte, assayed. Page • 65 • {1} Page • 66 • # 3. Predicate Device: Product: Dade CK-MB/Myoglobin Immunoassay Control Level 1,2 and 3 Catalog: Level 1 (B5200-1), Level 2 (B5200-2), Level 3 (B5200-3) Manufacturer: Baxter Diagnostics, Inc., Deerfield, IL 60015-4633 Analytes: CK-MB, Myoglobin Product: Abbott IMx STAT CK-MB Controls, L, M, H Catalog: 7A28-10 Manufacturer: Abbott Laboratories, Abbott Park, IL 60064 Analytes: CK-MB Product: Bio-Rad Unassayed Chemistry Control (Human) Levels 1 and 2 Catalog: 16030 Manufacturer: Bio-Rad, ECS Division, Anaheim, CA 28506 Analytes: CK, LD Product: Beckman I.D-Zone Liquid CK Isoenzyme Control Catalog: 667990 Manufacturer: Beckman Instruments, Brea, CA Analytes: CK Product: Beckman I.D-Zone Normal LD Isoenzyme Liquid Control Catalog: 439090 Manufacturer: Beckman Instruments, Brea, CA Analytes: LD # 4. Product Description: **DOCUMENT**® **CARDIAC** Assayed Controls consist of three levels of a human serum matrix containing creatine kinase isoenzymes, lactate dehydrogenase isoenzymes 1 and 2, and myoglobin. The formulation design provides a liquid matrix intended for use on automated and semi-automated immunochemistry systems and clinical chemistry systems for the determination of total creatine kinase activity (CK), creatine kinase MB mass (CKMB), creatine kinase immunoinhibition (CKII), creatine kinase electrophoresis (CKELEC), total lactate dehydrogenase activity (LD), lactate dehydrogenase electrophoresis for isoenzyme 1 and 2 (LD1; LD2), and myoglobin (MYO). # 5. Intended Use: This product is intended for *in vitro* diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies. {2} 6. Comparison to the Predicate Device: | Characteristic | DOCUMENT CARDIAC Assayed Control | Dade CK-MB/Myoglobin Immunoassay Control | Abbott CK-MB Stat Control | Bio-Rad Liquichek Unassayed Chemistry Control | | --- | --- | --- | --- | --- | | Intended Use | Assayed control for monitoring accuracy and precision of total CK and LD activity, CKMB immunoassay, CK Immunoinhibition, CK isoenzyme electrophoresis, LD1 and LD2 isoenzyme electrophoresis, myoglobin | Assayed control for monitoring of the accuracy and precision of CK-MB and myoglobin analysis | None indicated | Unassayed control for the monitoring of the accuracy and precision of automated and manual testing procedures | | Number of Levels | Three (3): Level I, Level II, Level III | Three (3): Level 1, Level 2, Level 3 | Three (3): Low, Mid, High | Two (2): Level 1, Level 2 | | Type | Assayed | Assayed | Assayed | Unassayed | | Analytes | 3 | 2 | 1 | Many | | Volume | 2 mL | 3 mL | 8 mL | 5 mL | | Matrix | Human serum, Liquid | Human source, Lyophilized | Bovine serum, Lyophilized | Human serum, Liquid | | Dilution | None required | None required | None required | None required | | Unopened Stability | Until Expiration Date | Until Expiration Date | Until Expiration Date | Until Expiration Date | | Open Stability | 45 Days | CKMB: 20 Days MYO: 14 Days | None indicated | 15 Days | | Container | Plastic, Dropper Tip | Glass | Plastic, Dropper Tip | Glass | Page • 67 • {3} 6. Comparison to the Predicate Device (Continued): | Characteristic | DOCUMENT CARDIAC Assayed Control | Beckman I.D-Zone Liquid CK Isoenzyme Control | Beckman I.D-Zone Liquid LD Isoenzyme Control | | --- | --- | --- | --- | | Intended Use | Assayed control for monitoring accuracy and precision of total CK and LD activity, CKMB immunoassay, CK Immunoinhibition, CK isoenzyme electrophoresis, LD1 and LD2 isoenzyme electrophoresis, myoglobin | Assayed control for monitoring the overall reliability of CK isoenzyme procedures | Assayed control for monitoring the overall reliability of LD isoenzyme electrophoretic procedures | | Number of Levels | Three (3): Level I, Level II Level III | One (1) | One (1) | | Type | Assayed | Assayed | Assayed | | Analytes | 3 | 1 | 1 | | Volume | 2 mL | 2 mL | 2 mL | | Matrix | Human serum, Liquid | Human serum albumin, Liquid | Human serum, Liquid | | Dilution | None required | None required | None required | | Unopened Stability | Until Expiration Date | Until Expiration Date | Until Expiration Date | | Open Stability | 45 Days | 20 Days | 20 Days | | Container | Plastic, Dropper Tip | Plastic Dropper Tip | Plastic, Dropper Tip | Page • 68 • {4} Page • 69 • # 7. Test Results: The equivalence for this product was carried out by comparing the inter-assay precision of the listed analytes of the DOCUMENT™ CARDIAC Assayed Control to that of Dade CK-MB/Myoglobin Immunoassay Controls, Abbott CK-MB Stat Controls, Bio-Rad Unassayed Chemistry Control, Beckman I.D-Zone Liquid CK Isoenzyme Control and Beckman I.D-Zone Normal LD Isoenzyme Liquid Control. The results show that the DOCUMENT™ CARDIAC Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K961750](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K961750) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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