ELECSYS CALCHECK PSA

K970458 · Boehringer Mannheim Corp. · JJX · Mar 6, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970458
• Device Name: ELECSYS CALCHECK PSA
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Boehringer Mannheim Elecsys CalCheck PSA is used to verify the calibration assignment for the Boehringer Mannheim Elecsys PSA assay.

Device Story

Elecsys CalCheck PSA consists of three-level lyophilized, human-based materials; used to verify calibration assignment for Elecsys PSA assay. Device requires reconstitution; assayed in triplicate; results compared to target values. Used in clinical laboratory settings by laboratory personnel. Output provides verification of assay calibration accuracy, ensuring reliable patient PSA test results.

Clinical Evidence

No clinical data. Performance characteristics based on value assignment and stability testing.

Technological Characteristics

Three-level lyophilized, human-based material set. Matrix: Bovine serum albumin. Analyte: PSA. Intended for use with Elecsys PSA assay.

Indications for Use

Indicated for use as a calibration verification material for the Elecsys PSA assay to verify calibration assignment.

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® CalCheck™ TSH (K963147)

Submission Summary (Full Text)

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K 970458
MAR - 6 1997

# 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
(510) 827 - 8215
Fax number: [phone]

Contact Person: Patricia M. Klimley

Date Prepared: January 29, 1997 |
| 2. Device Name | Proprietary name: Elecsys® CalCheck™ PSA

Common name: Calibration Verification Material

Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3. Predicate device | The Elecsys® CalCheck™ PSA is substantially equivalent to currently marketed, Elecsys® CalCheck™ TSH (K963147). |
| 4. Device Description | The Elecsys® CalCheck™ PSA is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values. |

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# 510(k) Summary, Continued

## 5. Intended use

The Boehringer Mannheim Elecsys CalCheck PSA is used to verify the calibration assignment for the Boehringer Mannheim Elecsys PSA assay.

## 6. Comparison to predicate device

The Elecsys® CalCheck™ PSA is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147).

The following table compares the Elecsys® CalCheck™ PSA with the predicate device, Elecsys® CalCheck™ TSH. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate devices is provided in attachment 6.

### Similarities:

- Configuration: 3 CalCheck levels: low, mid, and high
- Intended use: To verify calibration

### Differences:

| Feature | CalCheck PSA | CalCheck TSH |
| --- | --- | --- |
| Matrix type | Bovine serum albumin | Horse serum |
| Analyte | PSA | TSH |

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# 510(k) Summary, Continued

6. Comparison to predicate device, (cont.)

Performance Characteristics:
- Value assignment and stability