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The Emit® Calibrator B Level 1 and Calibrator B Level 2 are used in the calibration of the Emite d.a.u.™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/ml cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphen. A caws. The Emit Calibrator B Level 1 and Calibrator B Level 2 are also used in the calibration of the Emite II Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaquelone, Opiates 300/2000, and Propoxyphene Assays.

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

Behring Diagnostics Inc. is submitting this Premarket Notification, 510(k) to convey our intention to manufacture for commercial distribution a modified Emit® Calibrator B Level 1 (cutoff) and a modified Emit® Calibrator B Level 2 (high) used in the calibration of the Emit® d.a.u. ™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphene Assays. Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) are also used in the calibration of the Emit® II Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaqualone, Opiates 300/2000, and Propoxyphene Assays.

The modified Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) are substantially equivalent to the currently marketed Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) (K912729) with regard to intended use and overall performance characteristics. The most significant difference between the modified Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) is the addition of morphine at 2000 ng/mL in the Calibrator B Level 1 (cutoff) and morphine at 4000 ng/mL in the Calibrator B Level 2 (high).

The modified Calibrators B contain the following drug concentrations:

| | Level 1
(ng/mL) | Level 2
(ng/mL) |
|-----------------|--------------------|--------------------|
| Benzoylecgonine | 150 | 3000 |
| d-Amphetamine | 300 | 2000 |
| Methadone | 300 | 1000 |
| Methaqualone | 300 | 1500 |
| Morphine | 2000 | 4000 |
| Oxazepam | 300 | 1000 |
| Propoxyphene | 300 | 1000 |
| Secobarbital | 300 | 1000 |

This document describes the equivalence of a modified calibrator device (Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high)) to a previously marketed device (K912729). It does not describe a study proving a device meets acceptance criteria related to a general medical device or AI system. Instead, it demonstrates the substantial equivalence of a modified calibrator in the context of drug assays.

Therefore, many of the requested fields are not applicable to this type of submission. However, I can extract the relevant information and explain why other fields are not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of accuracy, precision, or other performance metrics usually seen for diagnostic devices. Instead, the "acceptance criteria" for this submission appear to be the demonstration of substantial equivalence to the predicate device in terms of intended use and overall performance characteristics. The key performance characteristic mentioned is the composition of the calibrator.

The key modification and reported performance are the new drug concentrations for the modified calibrators. The performance is that these new calibrators will function equivalently for their intended use in the listed assays.

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

• Sample Size: Not applicable. This document describes the composition change of a calibrator, not a study involving a test set of patient samples.
• Data Provenance: Not applicable. The "study" here is a submission demonstrating equivalence. No specific patient data or retrospective/prospective studies are detailed.

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

• Number of Experts: Not applicable. The "ground truth" for calibrators is their manufactured concentration, not an expert-derived diagnosis.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No. This is not a diagnostic device involving human readers or interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This product is a chemical calibrator; it does not involve algorithms or human-in-the-loop performance in the sense of AI. Its performance is related to its chemical composition and stability.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for a calibrator is its known, manufactured chemical concentrations of the listed substances. This is established through analytical chemistry and quality control during the manufacturing process.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI or machine learning device requiring a training set.

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

• Ground Truth Establishment: Not applicable.

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