(119 days)
Not Found
Not Found
No
The summary describes a quantitative in vitro diagnostic method for measuring valproic acid using standard laboratory techniques, with no mention of AI or ML.
No.
The device is an in vitro diagnostic (IVD) method used to measure drug levels for monitoring and overdose detection, not to directly treat or mitigate a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the method is "for in vitro diagnostic use" and measurements are used "as an aid in the diagnosis and treatment of valproic acid overdose."
No
The device is an in vitro diagnostic method intended to measure valproic acid in human serum and plasma using the Bayer ADVIA® IMS systems, which are hardware platforms. The performance studies describe analytical characteristics of the method on these systems, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "This in vitro method is intended to quantitatively measure the antiepileptic drug valproic acid in human serum and plasma..." and "The Bayer ADVIA IMS Valproic Acid method is for in vitro diagnostic use...". This directly aligns with the definition of an IVD, which are tests performed on samples taken from the human body to detect diseases, conditions, or infections.
- Sample Type: The method uses "human serum and plasma," which are biological samples taken from the human body.
- Purpose: The measurements are used "to aid in monitoring therapeutic levels of valproic acid to ensure appropriate therapy and in the treatment of valproic acid overdose." This indicates the results are used for medical purposes related to diagnosis, monitoring, and treatment.
The term "in vitro diagnostic use" is a clear indicator that the device falls under the IVD category.
N/A
Intended Use / Indications for Use
This in vitro method is intended to quantitatively measure the antiepileptic drug valproic acid in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of valproic acid are used to aid in monitoring therapeutic levels of valproic acid to ensure appropriate therapy and in the treatment of valproic acid overdose.
The Bayer ADVIA IMS Valproic Acid calibrator is for in vitro diagnostic use in the calibration of valproic acid using the ADVIA® IMS system.
The Bayer ADVIA IMS Valproic Acid method is for in vitro diagnostic use to measure the antiepileptic drug valproic acid in human serum and plasma. Measurements of valproic acid (2-propylpentanoic acid) are used as an aid in the diagnosis and treatment of valproic acid overdose, and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
LEG, DKB
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Minimum Detectable Concentration
| Method | ADVIA IMS | Centaur |
|---|---|---|
| MDC | 0.57 $\mu$ g/mL | 1.0 $\mu$ g/mL |
B. Imprecision
| ADVIA IMS | Bayer Centaur | ||
|---|---|---|---|
| Level | |||
| µg/mL | Total | ||
| CV (%) | Level | ||
| µg/mL | Total | ||
| CV(%) | |||
| 34.03 | 4.4 | 22.8 | 6.9 |
| 70.16 | 2.9 | 64.6 | 6.1 |
| 98.86 | 2.0 | 102.7 | 6.4 |
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 | 50 | $Y=0.98X + 4.9$ | 3.1 | 0.997 | 13.4 - 144 |
D. Interfering Substances
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Valproic acid
Concentration
μg/mL | Effect
(% change) |
|-----------------------------|-----------------------------------|-----------------------------------------|----------------------|
| Bilirubin
(unconjugated) | 25 | 112.01 | -3.3 |
| Bilirubin
(conjugated) | 25 | 108.71 | 2.3 |
| Hemoglobin | 600 | 107.13 | 3.1 |
| Lipids
(Triglycerides) | 750 | 102.67 | 9.8 |
E. Analytical Range
- 57ug/mL up to valproic acid concentration in highest calibrator (Level 6) (approximately 150 µg/mL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Valproic Acid Method for ADVIA® Modular System (IMS)™
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: // 0 4 2 8 0 7 = (leave blank)
1. Intended Use
This in vitro method is intended to quantitatively measure the antiepileptic drug valproic acid in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of valproic acid are used to aid in monitoring therapeutic levels of valproic acid to ensure appropriate therapy and in the treatment of valproic acid overdose.
Predicate Device 2.
| Product Name | Reagent Ref # | Calibrator Ref # |
|---|---|---|
| Bayer Centaur Valproic | ||
| Acid | 03783810 | |
| (129219) | 02700784 | |
| (129221) |
Device / Method 3.
| Product Name | Reagent Ref # | Calibrator Ref # |
|---|---|---|
| ADVIA IMS Valproic | ||
| Acid | 00329833 | 00419360 |
4. Performance
A. Minimum Detectable Concentration
| Method | ADVIA IMS | Centaur |
|---|---|---|
| MDC | 0.57 $\mu$ g/mL | 1.0 $\mu$ g/mL |
B. Imprecision
| ADVIA IMS | Bayer Centaur | ||
|---|---|---|---|
| Level | |||
| µg/mL | Total | ||
| CV (%) | Level | ||
| µg/mL | Total | ||
| CV(%) | |||
| 34.03 | 4.4 | 22.8 | 6.9 |
| 70.16 | 2.9 | 64.6 | 6.1 |
| 98.86 | 2.0 | 102.7 | 6.4 |
1
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 | 50 | $Y=0.98X + 4.9$ | 3.1 | 0.997 | 13.4 - 144 |
D. Interfering Substances
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Valproic acid
Concentration
μg/mL | Effect
(% change) |
|-----------------------------|-----------------------------------|-----------------------------------------|----------------------|
| Bilirubin
(unconjugated) | 25 | 112.01 | -3.3 |
| Bilirubin
(conjugated) | 25 | 108.71 | 2.3 |
| Hemoglobin | 600 | 107.13 | 3.1 |
| Lipids
(Triglycerides) | 750 | 102.67 | 9.8 |
E. Analytical Range
- 57ug/mL up to valproic acid concentration in highest calibrator (Level 6) (approximately 150 µg/mL).
Rin Ha
10/4/04
Date
Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York, 10591 - 5097
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract symbol, which is often interpreted as representing the human form.
FEB - 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andres Holle Manager, Regulatory Affairs Bayer Healthcare, LLC. Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591
K042807 Re:
Trade/Device Name: ADVIA® IMS Valproic Acid Method ADVIA® IMS Valproic Acid Calibrator Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: LEG, 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
.
3
Page 2 -
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
4
Indications for Use
510(k) Number (if known): _K042807
Device Name: ADVIA® IMS Valproic Acid Calibrator
Indications For Use:
The Bayer ADVIA IMS Valproic Acid calibrator is for in vitro diagnostic use in the calibration of valproic acid using the ADVIA® IMS system.
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)
Division Sign-Off
Division Slop-02
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Se
51062
5
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: ADVIA® IMS Valproic Acid Method
Indications For Use:
The Bayer ADVIA IMS Valproic Acid method is for in vitro diagnostic use to measure the antiepileptic drug valproic acid in human serum and plasma. Measurements of valproic acid (2-propylpentanoic acid) are used as an aid in the diagnosis and treatment of valproic acid overdose, and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.
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)
Albert CR
Division Slari-Of
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Satety
Lo420807
'