(44 days)
No
The summary describes a set of calibrators for drug assays, which are chemical reagents used to establish a standard curve for measurement. There is no mention of any computational or algorithmic processing, let alone AI/ML.
No
This device is a calibrator used to ensure the accuracy of assays for therapeutic drug monitoring. It is not directly used to treat or diagnose a disease, but rather to aid in the accurate measurement of drug levels in a patient's body, which then guides therapeutic decisions.
No
The device is described as a calibrator used to calibrate CEDIA assays for various drugs in human serum and plasma. This indicates it is a reference material for laboratory tests, not a device that directly diagnoses a medical condition. Its function is to ensure the accuracy of diagnostic assays.
No
The device description explicitly states the calibrators are manufactured using physical components like bovine serum albumin, drugs, stabilizers, and preservatives, indicating it is a physical product, not software.
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 measuring specific drugs in human serum and plasma. This indicates that the device is used to perform tests on samples taken from the human body.
- Device Description: The description mentions that the calibrators are used with CEDIA assays, which are themselves IVD tests used to measure drug levels in biological samples.
- Predicate Devices: The listed predicate devices are all CEDIA assays for measuring drug levels, which are known IVD products.
The function of a calibrator in an IVD assay is to establish a known relationship between the signal produced by the assay and the concentration of the analyte (in this case, the drugs) in the sample. This is a fundamental component of quantitative IVD testing.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
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.
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K914857, K904413, K905689, K961462, 930734/2
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Corporation |
| 2400 Bisso Lane | |
| Concord, CA 94524-4117 | |
| (510) 674-0690 extension 8415 | |
| Contact Person: Mary Koning | |
| Date Prepared: April 26, 1996 | |
| 2. Device name | Proprietary name: CEDIA Core TDM Multi-Cals |
| Common 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. |
Continued on next page
1
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 assays
for carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid
in human serum and plasma. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.
Comparison
to predicate
device | The Boehringer Mannheim CEDIA Core TDM Multi-Cals are substantially
equivalent 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 the
predicate devices, CEDIA Carbamazepine, Phenobarbital, Phenytoin,
Theophylline, and Valproic Acid 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 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 |
Continued on next page
2
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 Vial | ||
| Stability | Stable for 30 days | Stable for 30 days |
· Method Comparison: equivalent correlation between kit calibrators and CEDIA Core TDM Multi-Cals
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Aa