(119 days)
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No
The summary describes a standard in vitro diagnostic assay for measuring carbamazepine levels, with no mention of AI, ML, or related concepts.
No
This device is for in vitro diagnostic use, meaning it's used to analyze samples from the human body, but not directly for treating patients. The results aid treatment, but the device itself does not provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the measurements are "used as an aid in the diagnosis and treatment of carbamazepine overdose".
No
The device is an in vitro diagnostic method that measures carbamazepine in human serum and plasma using the Bayer ADVIA® IMS systems, which are hardware instruments.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "for in vitro diagnostic use". It describes measuring a substance (carbamazepine) in human samples (serum and plasma) to aid in diagnosis and treatment.
- Device Description: Also states "This in vitro method is intended to quantitatively measure... in human serum and plasma".
- Calibration: The calibrator is also described as "for in vitro diagnostic use".
These points clearly indicate that the device is intended to be used outside of the body to examine specimens for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bayer ADVIA IMS Carbamazepine method is for in vitro diagnostic use to measure the antiepileptic drug carbamazepine in human serum and plasma. Measurements of carbamazepine are used to aid in monitoring therapeutic levels of carbamazepine to ensure appropriate therapy and in the treatment of carbamazepine overdose.
The Bayer ADVIA IMS Carbamazepine calibrator is for in vitro diagnostic use in the calibration of carbamazepine using the ADVIA® IMS system.
Product codes (comma separated list FDA assigned to the subject device)
KLT, DKB
Device Description
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Minimum Detectable Concentration
Method: ADVIA IMS, MDC: 0.20 µg/mL
Method: Centaur, MDC: 0.25 µg/mL
B. Imprecision
ADVIA IMS:
Level µg/mL: 2.62, Total CV (%): 4.6
Level µg/mL: 5.63, Total CV (%): 2.6
Level µg/mL: 9.19, Total CV (%): 2.5
Bayer Centaur:
Level µg/mL: 3.28, Total CV(%): 9.2
Level µg/mL: 5.79, Total CV(%): 8.2
Level µg/mL: 9.85, Total CV(%): 8.4
C. Correlation (Y-ADVIA IMS, X-Comparison system)
Specimen type: Serum, Comparison System (X): Centaur, N: 48, Regression Equation: Y=1.00X + 0.01, Syx μg/mL: 0.80, R: 0.988, IMS Sample Range μg/mL: 1.2 to 17.6
D. Interfering Substances
Interfering Substance: Bilirubin (unconjugated), Interfering Sub. Conc. (mg/dL): 25, Carbamazepine Concentration µg/mL: 14.47, Effect (% change): 2.0
Interfering Substance: Bilirubin (conjugated), Interfering Sub. Conc. (mg/dL): 25, Carbamazepine Concentration µg/mL: 14.64, Effect (% change): -3.9
Interfering Substance: Hemoglobin, Interfering Sub. Conc. (mg/dL): 600, Carbamazepine Concentration µg/mL: 14.59, Effect (% change): -0.7
Interfering Substance: Lipids (Triglycerides), Interfering Sub. Conc. (mg/dL): 750, Carbamazepine Concentration µg/mL: 13.60, Effect (% change): -8.4
E. Analytical Range
0.20 µg/mL to carbamazepine concentration in highest calibrator (Level 6) (22.14 µg/mL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Bayer Centaur Carbamazepine
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS -- 516(R) SUMMART OF SALD For AND 21 2 000 -----------------------------------------------------------------------------------------------------------------------------------
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K042808 (leave blank)
1. Intended Use
This in vitro method is intended to quantitatively measure the antiepileptic drug carbamazepine in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of carbamazepine are used to aid in monitoring therapeutic levels of carbamazepine to ensure appropriate therapy and in the treatment of carbamazepine overdose.
Predicate Device 2.
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| Bayer Centaur | 07862715 | 05706449 |
| Carbamazepine | (119933) | (107585) |
Device / Method 3.
| Product Name | Reagent | Calibrator |
|---|---|---|
| ADVIA IMS | ||
| Carbamazepine | 00328780 | 00417120 |
Performance 4.
A. Minimum Detectable Concentration
| Method | ADVIA IMS | Centaur |
|---|---|---|
| MDC | $0.20 \mu g/mL$ | $0.25 \mu g/mL$ |
B. Imprecision
| ADVIA IMS | |
|---|---|
| Level | |
| µg/mL | Total |
| CV (%) | |
| 2.62 | 4.6 |
| 5.63 | 2.6 |
| 9.19 | 2.5 |
| Bayer Centaur | |
|---|---|
| Level | |
| µg/mL | Total |
| CV(%) | |
| 3.28 | 9.2 |
| 5.79 | 8.2 |
| 9.85 | 8.4 |
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| C. Correlation (Y-ADVIA IMS, X-Comparison system) | ||||||
|---|---|---|---|---|---|---|
| Specimen type | Comparison System (X) | N | Regression Equation | Syx μg/mL | R | IMS Sample Range μg/mL |
| Serum | Centaur | 48 | $Y=1.00X + 0.01$ | 0.80 | 0.988 | 1.2 to 17.6 |
C Correlation (V=ADVIA IMS. X = Comparison system)
D. Interfering Substances
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Carbamazepine
Concentration
µg/mL | Effect
(% change) |
|-----------------------------|-----------------------------------|-----------------------------------------|----------------------|
| Bilirubin
(unconjugated) | 25 | 14.47 | 2.0 |
| Bilirubin
(conjugated) | 25 | 14.64 | -3.9 |
| Hemoglobin | 600 | 14.59 | -0.7 |
| Lipids
(Triglycerides) | 750 | 13.60 | -8.4 |
E. Analytical Range
0.20 µg/mL to carbamazepine concentration in highest calibrator (Level 6) (22.14 µg/mL).
A. Auda
10/4/04
Date
Date
Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York, 10591 - 5097
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its head, representing health, human services, and the pursuit of well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 8 2005
Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591
Re: K042808
Trade/Device Name: ADVIA® IMS Carbamazepine Method ADVIA® IMS Carbamazepine Calibrator Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: KLT, DKB Dated: October 4, 2004 Received: October 13, 2004
Dear Mr. Holle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Jean M. Cooper MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: ADVIA® IMS Carbamazepine Method
Indications For Use:
The Bayer ADVIA IMS Carbamazepine method is for in vitro diagnostic use to The Bayer ADVIA The Ourbancepine in human serum and plasma. measure the anticplicplio drug carbarness, mazepine-5-carboxamide) are Measurements of ourbamazepine (17) (17) and treatment of carbamazepine overdose, and used as an ald in the diagnools and treamezepine to ensure appropriate therapy.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mert
Division Sign-Off
Division Sign-Off
Office of In Vitro Dia
042808
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Indications for Use
510(k) Number (if known): _ K042808
Device Name: ADVIA® IMS Carbamazepine Calibrator
Indications For Use:
The Bayer ADVIA IMS Carbamazepine calibrator is for in vitro diagnostic use in the calibration of carbamazepine using the ADVIA® IMS system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Division Sign-
Office of In Vitro Diag Device Evaluation
5100
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