CEDIA CARDIAC TDM MULTI-CALS

• K Number: K962269
• Device Name: CEDIA CARDIAC TDM MULTI-CALS
• Manufacturer: BOEHRINGER MANNHEIM CORP.
• Date Cleared: 1996-10-29 ( 138 days)
• Product Code: JIX
• Regulation Number: 862.1150

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 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.

Predicate Devices

K910642, K834464, K830206

Reference Devices

K910642, K834464, K830206

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes calibrators for in-vitro diagnostic assays, which are chemical reagents used for calibration. There is no mention of any computational or algorithmic components, let alone AI/ML.

Therapeutic

No

This device is described as a calibrator for assays, used to test human serum and plasma. It does not directly treat or diagnose a disease, nor does it affect the structure or function of the body. Its purpose is to ensure the accurate measurement of certain substances.

Diagnostic

No

This device is described as a calibrator for assays, used to ensure correct assay calibration for measuring specific drugs in human serum and plasma. It aids in the accurate functioning of diagnostic assays but is not a diagnostic device itself.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is manufactured using physical components (bovine serum albumin, digoxin, N-acetylprocainamide, procainamide, stabilizers, and preservatives) and is a calibrator for laboratory assays, not a software product.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states that the calibrators are used to calibrate assays for digoxin, N-acetylprocainamide, and procainamide in human serum and plasma. This indicates that the device is intended for use in examining specimens derived from the human body to provide information for diagnostic purposes.
• Device Description: The description mentions that the calibrators are used to ensure correct assay calibration for the CEDIA assays. These assays are used to measure the levels of specific substances in human samples, which is a core function of IVDs.
• Predicate Devices: The predicate devices listed (CEDIA Digoxin, TDx Procainamide, TDx N-acetylprocainamide Assays) are all IVD assays used for therapeutic drug monitoring (TDM). Calibrators are essential components of such IVD systems.

Therefore, based on the provided information, the CEDIA Cardiac TDM Multi-Cals are clearly intended for use in an in vitro diagnostic context.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

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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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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

Key Metrics

Not Found

Predicate Device(s)

K910642, K834464, K830206

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
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.)(b)
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.

Summary

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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.
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 in provided in attachment 6.
	Similarities:

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510(k) Summary, Continued

· 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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ટેસ

510(k) Summary, Continued

Performance Characteristics: 6. Comparison to predicate device, (cont.)

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