ELECSYS PRECICONTROL CARDIAC

K962575 · Boehringer Mannheim Corp. · JJY · Jul 22, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962575
• Device Name: ELECSYS PRECICONTROL CARDIAC
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Control for Elecsys® CK-MB and Troponin-T assays.

Device Story

Elecsys® PreciControl Cardiac 1 and 2 are human serum albumin-based control materials containing CK-MB and Troponin-T. Used in clinical laboratory settings to monitor the performance of Elecsys® CK-MB and Troponin-T assays on the Elecsys® 2010 system. The product is reconstituted with 2 mL of distilled water and stored at 2-8°C. Healthcare providers use the control results to verify assay accuracy and precision, ensuring reliable diagnostic output for cardiac marker testing.

Clinical Evidence

No clinical data. Bench testing only, comparing target concentrations and stability profiles against predicate devices.

Technological Characteristics

Human serum matrix control material. Analytes: CK-MB and Troponin-T. Reconstitution: 2 mL distilled water. Storage: 2-8°C. Application: Elecsys® 2010 test system.

Indications for Use

Indicated for use as a quality control material to monitor the performance of Elecsys® CK-MB and Troponin-T assays.

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

• Elecsys® CK-MB CalSet (K961501)
• Elecsys® Troponin-T CalSet (K961500)

Submission Summary (Full Text)

{0}

K962575
JUL 22 1996
510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| --- | --- |
| 1. Submitter name, address, contact | Boehringer Mannheim Corporation
2400 Bisso Lane
Concord, CA 94524-4117
[phone]

Contact Person: Patricia Klimley

Date Prepared: June 28, 1996 |
| 2. Device name | Proprietary name: Elecsys® PreciControl Cardiac 1 and 2

Common name: Control material

Classification name: Enzyme controls (Assayed and Unassayed) |
| 3. Predicate device | The Boehringer Mannheim Elecsys® PreciControl Cardiac 1 and 2 are substantially equivalent to the Elecsys® CK-MB and Elecsys® Troponin-T CalSets (K961501 & K961500). The intended use has been changed to a quality control material. |

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{1}

Coehringer Diagnostics

# 510(k) Summary, Continued

4. Device Description
Human serum albumin control with CK-MB and Troponin-T for use in CK-MB and Troponin-T assays.

5. Intended use
Control for Elecsys® CK-MB and Troponin-T assays.

6. Comparison to predicate device
The Boehringer Mannheim Elecsys® PreciControl Cardiac 1 and 2 are substantially equivalent to the Elecsys® CK-MB and Elecsys® Troponin-T CalSets (K961501 & K961500). The intended use has been changed to a quality control material.

The following table compares the Elecsys® PreciControl Cardiac 1 and 2 with the predicate device, Elecsys® CK-MB and Elecsys® Troponin-T CalSets (K961501 & K961500).

## Similarities:
- Same matrix: Human serum matrix
- Same analytes: CK-MB and Troponin-T
- Standardization: CK-MB - commercially available CK-MB test, Troponin-T - highly purified bovine cardiac troponin-T.
- Storage conditions: 2 - 8°C
- Application test system: Elecsys® 2010
- Reconstitution: 2 mL distilled water
- Manufacturer: Boehringer Mannheim Germany

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Diagnostics

# 510(k) Summary, Continued

## 6. Comparison to predicate device cont.

### Differences:

| Feature | Elecsys® CK-MB and Troponin-T CalSet | Elecsys® PreciControl Cardiac |
| --- | --- | --- |
| Target concentration | CK-MB: 0.15 and 500 ng/mL (approximately)
Troponin-T: 0.021 and 25 ng/mL (approximately) | CK-MB: 6.0 and 60 ng/mL (approximately)
Troponin-T: 0.2 and 6.0 ng/mL (approximately) |
| Intended Use | Calibration of the Elecsys CK-MB and Troponin-T Assays | Monitoring assays for CK-MB and Troponin-T |
| Open vial stability | 2 weeks at 2 - 8°C | 3 days at 2 - 8°C |

### Performance Characteristics:

| Feature | Elecsys® CK-MB and Troponin-T CalSet | Elecsys® PreciControl Cardiac |
| --- | --- | --- |
| Open Vial Stability | 2 weeks at 2 - 8°C | 3 days at 2 - 8°C |
| Value Assignment | CK-MB: 0.15 and 500 ng/mL (approximately)
Troponin-T: 0.021 and 25 ng/mL (approximately) | CK-MB: 6.0 and 60 ng/mL (approximately)
Troponin-T: 0.2 and 6.0 ng/mL (approximately) |

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