(44 days)
The CEDIA Core TDM Multi-Cals are used to calibrate the CEDIA assays for carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid in human serum and plasma.
The CEDIA Core TDM Calibrators are manufactured using bovine serum albumin, carbamazepine, phenobarbital, phenytoin, theophylline, valproic acid, 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.
This 510(k) summary describes a medical device, the "CEDIA Core TDM Multi-Cals," which are calibrators for therapeutic drug monitoring assays. The document focuses on establishing substantial equivalence to existing predicate devices (kit calibrators). It does not contain information about a study proving the device meets acceptance criteria in the sense of a clinical performance study for an AI/CADe device. Instead, the "performance characteristics" section refers to comparisons with predicate devices and stability.
Therefore, many of the requested categories for a study proving device performance are not applicable to this type of submission. I will address the relevant safety and performance information provided.
Acceptance Criteria and Study for CEDIA Core TDM Multi-Cals
This 510(k) submission describes calibrators, not an active diagnostic device that produces interpretative results. As such, the "acceptance criteria" and "device performance" are focused on properties relevant to calibration efficacy and stability, rather than diagnostic accuracy metrics like sensitivity or specificity. The "study" referenced is a method comparison and stability assessment against predicate calibrators.
| Acceptance Criteria Category | Reported Device Performance (CEDIA Core TDM Multi-Cals) |
|---|---|
| Method Comparison (correlation with predicate calibrators) | Equivalent correlation with predicate device kit calibrators for: - Carbamazepine - Phenobarbital - Phenytoin - Theophylline - Valproic Acid |
| Open Vial Stability | Stable for 30 days |
| Formulation | Similar formulation to predicate devices |
| Concentrations of Drugs | Similar concentrations to predicate devices |
| Intended Use | For calibration of CEDIA assays in human serum and plasma |
Explanation of Non-Applicability for AI/CADe Device Performance Study Criteria:
Many of the requested points are relevant for performance studies of AI/CADe devices (imaging analysis, disease detection, etc.), which yield specific diagnostic outputs. This 510(k) submission is for calibrators, which are reagents used to standardize analytical instruments. Their "performance" is assessed by their ability to provide accurate and stable calibration curves, ensuring the analytical system yields correct drug concentration measurements when analyzing patient samples.
Therefore, the following points are not applicable to this submission:
- Sample size used for the test set and data provenance: No "test set" of patient data is used in the context of diagnostic performance. The evaluation involves method comparison of calibrator performance.
- Number of experts used to establish the ground truth for the test set and their qualifications: No "ground truth" in the clinical diagnostic sense is established by experts for a calibrator. Ground truth for drug concentrations would typically be established by highly accurate reference methods.
- Adjudication method: Not applicable for calibrator evaluation.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an interpretive diagnostic device.
- Standalone (algorithm only) performance: Not applicable, as this is a reagent, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for calibrators would be their assigned concentration values, which are established by comparison to reference materials or methods, not by expert consensus or pathology. The document states they are "value assigned by comparison to the predicate device."
- Sample size for the training set: Not applicable; there is no "training" of an algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information from the Document:
The study proving the device meets its performance characteristics (i.e., its suitability as a calibrator) is described as follows:
- Method Comparison: The CEDIA Core TDM Multi-Cals demonstrated "equivalent correlation" with the predicate device kit calibrators. This implies that when used to calibrate the assays, the results obtained using the new calibrators are comparable to those obtained using the predicate calibrators.
- Open Vial Stability: The calibrators were shown to be stable for 30 days once opened.
- Manufacturing Control: 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." This process establishes their "ground truth" (assigned values) and ensures consistency.
In essence, the study validates that the new multi-calibrators perform equivalently to the individual kit calibrators they are intended to replace, with acceptable stability, thereby meeting the necessary performance for their intended use.
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K961659 Diagnostics
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 8415Contact Person: Mary KoningDate Prepared: April 26, 1996 |
| 2. Device name | Proprietary name: CEDIA Core TDM Multi-CalsCommon name: Therapeutic drug monitoring calibrators for use in the calibration of the CEDIA assays for carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid.Classification name: Calibrators, drug mixture |
| 3. Predicate device | The Boehringer Mannheim CEDIA Core TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA Carbamazepine (K914857), Phenobarbital (K904413), Phenytoin (K905689), Theophylline (K961462), and Valproic Acid (930734/2) Assays. |
| 4. Device Description | The CEDIA Core TDM Calibrators are manufactured using bovine serum albumin, carbamazepine, phenobarbital, phenytoin, theophylline, valproic acid, 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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Image /page/1/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of a black square with the word "mannheim" written vertically on the left side. 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.
510(k) Summary, Continued
| 5.Intended use | The CEDIA Core TDM Multi-Cals are used to calibrate the CEDIA assaysfor carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acidin human serum and plasma. |
|---|---|
| 6.Comparisonto predicatedevice | The Boehringer Mannheim CEDIA Core TDM Multi-Cals are substantiallyequivalent to the CEDIA Carbamazepine (K914857), Phenobarbital(K904413), Phenytoin (K905689), Theophylline (K961462), Valproic Acid(930734/2) Assays.The following table compares the CEDIA Core TDM Multi-Cals with thepredicate devices, CEDIA Carbamazepine, Phenobarbital, Phenytoin,Theophylline, and Valproic Acid assay's kit calibrators. Specific data on theperformance of the test have been incorporated into the draft labeling inattachment 5. Labeling for the predicate device in provided in attachment 6. |
| Similarities: | |
| • Similar formulation. | |
| • Similar concentrations of carbamazepine, phenobarbital, phenytoin,theophylline, and valproic acid. | |
| • For the calibration of the CEDIA Carbamazepine, Phenobarbital,Phenytoin, Theophylline, and Valproic Acid assays. | |
| Differences: |
| Feature | Core TDM Multi-Cals | Kit Calibrators |
|---|---|---|
| Configuration | sold separately from reagents | sold with reagents in kit |
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Image /page/2/Picture/0 description: The image shows the logo for Mannheim 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 square is the word "Diagnostics" in a serif font.
510(k) Summary, Continued
Performance Characteristics:
- Comparison to predicate device, (cont.)
| Feature | Core TDM Multi-Cals | Kit Calibrators |
|---|---|---|
| Open VialStability | Stable for 30 days | Stable for 30 days |
· Method Comparison: equivalent correlation between kit calibrators and CEDIA Core TDM Multi-Cals
page 23
Aa
§ 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.