CEDIA CARDIAC TDM MULTI-CALS

K962269 · Boehringer Mannheim Corp. · JIX · Oct 29, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962269
• Device Name: CEDIA CARDIAC TDM MULTI-CALS
• Applicant: Boehringer Mannheim Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The CEDIA Cardiac TDM Multi-Cals are used to calibrate the CEDIA assays for digoxin, N-acetylprocainamide, and procainamide, in human serum and plasma.

Device Story

CEDIA Cardiac TDM Multi-Cals are liquid calibrators used to calibrate clinical chemistry assays for therapeutic drug monitoring of digoxin, N-acetylprocainamide, and procainamide. The device consists of a bovine serum albumin matrix spiked with specific concentrations of the target drugs, stabilizers, and preservatives. Used in clinical laboratory settings by laboratory technicians to establish calibration curves for automated analyzers. The output is a set of reference values used to quantify drug concentrations in patient serum or plasma samples, ensuring accurate therapeutic drug monitoring and clinical decision-making regarding dosage adjustments.

Clinical Evidence

Bench testing only. Performance characteristics established via method comparison studies demonstrating equivalent correlation between the subject device and predicate device kit calibrators.

Technological Characteristics

Calibrator matrix composed of bovine serum albumin, digoxin, N-acetylprocainamide, procainamide, stabilizers, and preservatives. Sold as a multi-calibrator set separate from assay reagents. Quality control performed against in-house reference calibrators value-assigned by comparison to predicate devices.

Indications for Use

Indicated for the calibration of CEDIA assays for digoxin, N-acetylprocainamide, and procainamide in human serum and plasma samples.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• CEDIA Digoxin (K910642)
• TDx Procainamide (K834464)
• TDx N-acetylprocainamide (K830206)

Submission Summary (Full Text)

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K962269 OCT 29 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] extension 8415

Contact Person: Mary Koning

Date Prepared: October 25, 1996 |
| 2. Device name | Proprietary name: CEDIA Cardiac TDM Multi-Cals

Common name: Therapeutic drug monitoring calibrators for use in the calibration of the CEDIA assays for digoxin, N-acetylprocainamide, and procainamide.

Classification name: Calibrators, drug mixture |
| 3. Predicate device | The Boehringer Mannheim CEDIA Cardiac TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA Digoxin (K910642), TDx Procainamide (K834464), and TDx N-acetylprocainamide (K830206) Assays. |
| 4. Device Description | The CEDIA Cardiac TDM Calibrators are manufactured using bovine serum albumin, digoxin, N-acetylprocainamide, procainamide, stabilizers, and preservatives. The drugs are appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have been value assigned by comparison to the predicate device to ensure correct assay calibration. |

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# 510(k) Summary, Continued

## 5. Intended use
The CEDIA Cardiac TDM Multi-Cals are used to calibrate the CEDIA assays for digoxin, N-acetylprocainamide, and procainamide, in human serum and plasma.

## 6. Comparison to predicate device
The Boehringer Mannheim CEDIA Cardiac TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA Digoxin (K910642), TDx Procainamide (K834464), and TDx N-acetylprocainamide (K830206) Assays.

The following table compares the CEDIA Cardiac TDM Multi-Cals with the predicate devices, CEDIA Digoxin, TDx Procainamide, and TDx N-acetylprocainamide assay's kit calibrators. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6.

### Similarities:
- Similar concentrations of digoxin, N-acetylprocainamide, and procainamide.

### Differences:
| Feature | Cardiac TDM Multi-Cals | Kit Calibrators |
| --- | --- | --- |
| Configuration | sold separately from reagents | sold with reagents in kit |
| Number of calibrators in set (N-acetylprocainamide, Procainamide) | 2 | 6 |
| Matrix | Bovine Serum Albumin | Human Serum |

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# 510(k) Summary, Continued

6. Comparison to predicate device, (cont.)

## Performance Characteristics:

- Method Comparison: equivalent correlation between predicate device kit calibrators and CEDIA Cardiac TDM Multi-Cals.

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