(26 days)
No
The summary describes calibrators for a drug assay, which are chemical reagents, not a software or hardware device that would typically incorporate AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is a calibrator for assays, not a treatment or diagnostic device for human health.
No
The device is described as a calibrator for assays, not a device that itself diagnoses a condition or disease.
No
The device description clearly states it is manufactured using physical components like bovine serum albumin, tobramycin, gentamicin, 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 device is used to "calibrate the CEDIA assays for tobramycin and gentamicin in human serum and plasma." This indicates that the device is used in vitro (outside the body) to analyze biological samples (human serum and plasma) for diagnostic purposes (measuring drug levels).
- Device Description: The description mentions the device is manufactured using bovine serum albumin and spiked with drugs, further supporting its use as a reagent or calibrator for laboratory testing.
- Predicate Devices: The mention of predicate devices (CEDIA tobramycin and gentamicin assays) which are themselves IVDs, strongly suggests that this calibrator is also an IVD, as it is designed to be used with those assays.
Therefore, based on the provided information, the CEDIA Antibiotic TDM Multi-Cals fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CEDIA Antibiotic TDM Multi-Cals are used to calibrate the CEDIA assays for tobramycin and gentamicin in human serum and plasma.
Product codes
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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
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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 Antibiotic TDM Multi-Cals.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 Corporation |
| 2400 Bisso Lane | |
| Concord, CA 94524-4117 | |
| (510) 674-0690 extension 8240 |
Contact Person: Betsy Soares-Maddox
Date Prepared: August 14, 1996 |
| 2. Device name | Proprietary name: CEDIA Antibiotic TDM Multi-Cals
Common 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
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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.
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| 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 |
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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.