CEDIA ANTIBIOTIC TDM MULTI-CALS by BOEHRINGER MANNHEIM CORP.

The CEDIA Antibiotic TDM Calibrators are manufactured using bovine serum albumin, tobramycin, gentamicin, 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

AI/ML Overview

This document describes a 510(k) Summary for CEDIA Antibiotic TDM Multi-Cals, which are calibrators for tobramycin and gentamicin assays. The summary focuses on establishing substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, many of the requested categories (such as AI improvement, standalone performance, training set details, and expert adjudication) are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating substantially equivalent correlation between the new CEDIA Antibiotic TDM Multi-Cals and the kit calibrators of existing CEDIA tobramycin and gentamicin assays (predicate devices).

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent correlation between predicate device kit calibrators and new calibrators (for tobramycin and gentamicin assays)	Method Comparison: "equivalent correlation between predicate device kit calibrators and CEDIA Antibiotic TDM Multi-Cals."

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5." However, the provided text does not include the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective study design).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This concept is not applicable to this type of device (calibrators). The "ground truth" for calibrators is typically established by precise chemical or analytical methods, not by expert interpretation.

4. Adjudication Method for the Test Set:

Not applicable for this type of device. Adjudication methods are relevant for human interpretation of clinical data, not for calibrator performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, this is not an AI/ML powered device. An MRMC study would not be relevant in this context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a set of calibrators, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the calibrators themselves is established by precise chemical spiking and value assignment. The document states: "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..." (the sentence is cut off, but implies a reference method).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This device does not have a training set.

Summary

{0}------------------------------------------------

ל 963191 Diagnostics n mahr

SEP 1 0 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 Corporation2400 Bisso LaneConcord, CA 94524-4117(510) 674-0690 extension 8240Contact Person: Betsy Soares-MaddoxDate Prepared: August 14, 1996
2. Device name	Proprietary name: CEDIA Antibiotic TDM Multi-CalsCommon name: Therapeutic drug monitoring calibrators for use in the calibration of the CEDIA assays for tobramycin and gentamicin.Classification name: Calibrators, drug mixture
3. Predicate device	The Boehringer Mannheim CEDIA Antibiotic TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA tobramycin (K912143) and gentamicin (K913470) assays.
4. Device Description	The CEDIA Antibiotic TDM Calibrators are manufactured using bovine serum albumin, tobramycin, gentamicin, 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

نيتي پيريو نه

Continued on next page

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the word "mannheim" written vertically on the left side of a black square. Inside the square is a circle with the word "boehringer" written inside. To the right of the logo is the word "Diagnostics" in a serif font.

ﺇ

5. Intended use	The CEDIA Antibiotic TDM Multi-Cals are used to calibrate the CEDIA assays for tobramycin and gentamicin in human serum and plasma.
6. Comparison to predicate device	The Boehringer Mannheim CEDIA Antibiotic TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA tobramycin (K912143) and gentamicin (K913470) assays.

The following table compares the CEDIA Antibiotic TDM Multi-Cals with the predicate devices, CEDIA Tobramycin and Gentamicin 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:

• Similar concentrations of tobramycin and gentamicin.

Differences:

Feature	Antibiotic TDM Multi-Cals	Kit Calibrators
Configuration	sold separately from reagents	sold with reagents in kit

Continued on next page

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image contains the logo for Boehringer Diagnostics. The logo consists of a black square with a white circle inside, with the word "boehringer" written in white inside the circle. To the left of the circle, the word "mannheim" is written vertically in white. To the right of the logo, the word "Diagnostics" is written in a serif font.

510(k) Summary, Continued

ર. Comparison to predicate device, (cont.)

Performance Characteristics:

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

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.