DOCUMENT CARDIAC ASSAYED CONTROL

K961750 · Casco Standards · JJY · Jul 22, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961750
• Device Name: DOCUMENT CARDIAC ASSAYED CONTROL
• Applicant: Casco Standards
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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.

Indications for Use

Indicated for use as an assayed control material to monitor the accuracy and precision of immunochemistry and clinical chemistry systems measuring total creatine kinase (CK) activity, CK-MB mass, CK immunoinhibition, CK electrophoresis, total lactate dehydrogenase (LD) activity, LD isoenzyme electrophoresis (LD1, LD2), and myoglobin.

Regulatory Classification

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)

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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

[phone]
[phone] FAX

May 5, 1996

2. Product Name:

Proprietary Name: DOCUMENT® CARDIAC Assayed Control

Classification Name: Control, multiple analyte, assayed.

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# 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.

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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 |

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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 |

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# 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.