(60 days)
No
The description details a standard competitive chemiluminescence immunoassay, which is a well-established laboratory technique. There is no mention of AI, ML, or any computational analysis beyond the measurement of chemiluminescence and its inverse relationship to the analyte concentration. The performance studies focus on method comparison and correlation, typical for laboratory assays, not AI/ML model validation.
No
This device is an immunoassay designed to measure valproic acid levels in the blood, which aids in monitoring the effectiveness and toxicity of a therapeutic drug (valproic acid). It is a diagnostic tool, not a therapeutic device itself.
Yes
Explanation: The device is described as an immunoassay for the quantitative determination of valproic acid in human serum and plasma, used "as an aid to monitor patients' valproic acid level." This monitoring provides information used in patient management, which is characteristic of a diagnostic device.
No
The device description clearly outlines a chemiluminescence immunoassay that involves physical reagents (Lite Reagent, Solid Phase with paramagnetic particles) and a luminometer for measurement. This indicates a hardware-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of valproic acid in human serum and plasma." This involves testing samples taken from the human body.
- Device Description: The description details a "competitive chemiluminescence immunoassay" that uses "human serum and plasma" samples. This is a laboratory-based test performed on biological specimens.
- Purpose: The purpose is to "monitor patients' valproic acid level" to ensure therapeutic levels and avoid toxicity. This information is used to aid in patient management.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The ACS:180 and ADVIA Centaur Valproic Acid Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of valproic acid in human serum and plasma for use on the automated analyzers marketed by Bayer Corporation. Valproic acid (2-propylpentanoic acid) is an anticonvulsant that is used alone or in combination with other anticonvulsant drugs to control seizures. Monitoring of valproic acid ensures that there is adequate drug in the blood stream without being at toxic levels. The ACS:180 and ADVIA Centaur Valproic Acid Immunoassays are used as an aid to monitor patients' valproic acid level.
Product codes
LEG, DKB
Device Description
The ACS and ADVIA Centaur Valproic acid assay is a competitive chemiluminescence immunoassay intended for the quantitative determination of valproic acid in human serum and plasma. Valproic acid in the patient sample, calibrators, standards and controls competes with acridinium ester-labeled valproic acid in the Lite Reagent for a limited amount of monoclonal mouse anti-valproic acid antibody, which is covalently coupled to paramagnetic particles in the Solid Phase. Following incubation, non-reacted acridinium ester-labeled valproic acid and non-reacted valproic acid from the sample is washed from the reaction mixture. The chemiluminescence of the bound, labeled valproic acid is measured in a luminometer. The measured chemiluminescence is inversely proportional to the quantity of valproic acid in the sample.
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
Method Comparison: Substantial equivalence of the ACS and ADVIA Centaur Valproic acid assay to the predicate device is seen. These correlation studies demonstrate that the ACS:180 & ADVIA Centaur Valproic acid assay is equivalent to each other as well as the predicate device.
Sample Size:
TDx valproic acid vs. ADVIA Centaur Valproic acid: 250
TDx valproic acid vs. ACS:180 Valproic acid: 250
ACS:180 Valproic acid vs. ADVIA Centaur Valproic acid: 253
Key Metrics
Correlation Coefficient (r):
TDx valproic acid vs. ADVIA Centaur Valproic acid: 0.99
TDx valproic acid vs. ACS:180 Valproic acid: 0.99
ACS:180 Valproic acid vs. ADVIA Centaur Valproic acid: 0.99
Slope:
TDx valproic acid vs. ADVIA Centaur Valproic acid: 0.96
TDx valproic acid vs. ACS:180 Valproic acid: 0.98
ACS:180 Valproic acid vs. ADVIA Centaur Valproic acid: 0.97
Intercept:
TDx valproic acid vs. ADVIA Centaur Valproic acid: 4.03
TDx valproic acid vs. ACS:180 Valproic acid: 1.37
ACS:180 Valproic acid vs. ADVIA Centaur Valproic acid: 3.37
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.
0
JAN 2 9 2002
Summary of Safety and Effectiveness ASC:180 and ADVIA Centaur Valproic acid Immunoassay
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
3.1 Submitter Information
Contact person:
Address:
Kenneth T. Edds, Ph.D.
Bayer Diagnostics Corporation 511 Benedict Ave. Tarrytown, NY 10591
Phone: 914-524-2446 FAX: 914-524-2500 e-mail: ken.edds.b(@bayer.com
Date Summary Prepared:
November 12, 2001
3.2 Device Information
Proprietary Name:
ADVIA Centaur and ACS:180 Valproic Acid Immunoassay
Common Name:
Valproic acid Immunoassay
3.3 Predicate Device Information
Name:
TDx Valproic acid assay
Manufacturer:
510(k) number:
Abbott Laboratories Diagnostics Division Abbott Park, IL 60064
Device Description 3.4
The ACS and ADVIA Centaur Valproic acid assay is a competitive chemiluminescence immunoassay intended for the quantitative determination of valproic acid in human serum and plasma. Valproic acid in the patient sample, calibrators, standards and controls competes with acridinium ester-labeled valproic acid in the Lite Reagent for a limited amount of monoclonal mouse anti-valproic acid antibody, which is covalently coupled to paramagnetic particles in the Solid Phase. Following incubation, non-reacted acridinium ester-labeled valproic acid and non-reacted valproic acid from the sample is washed from the reaction mixture. The chemiluminescence of the bound, labeled valproic acid is measured in a luminometer. The measured chemiluminescence is inversely proportional to the quantity of valproic acid in the sample.
1
3.5 Statements of Intended Use - Comparison
ACS Valproic acid .
"For the quantitative determination of valproic acid in serum or plasma using the Tor the qualificacity cocci inminescent Systems. For In Vitro diagnostic use."
ADVIA Centaur Valproic acid ●
"For in vitro diagnostic use in the quantitative determination of valproic acid in serum or plasma using the ADVIA Centaur System."
TDx Valproic acid ●
"The TDx/TDxFLx Valproic acid assay is a reagent system for the quantitative measurement of valproic acid, an anticonvulsant drug, in serum or plasma. The measurements obtained are used in monitoring levels of valproic acid to ensure appropriate therapy."
Summary of Technological Characteristics 3.6
The ADVIA Centaur and ACS:180 Valproic Acid assay uses a competitive immunoassay format that employs paramagnetic particles and chemiluminescence technology. Both assays use the same reagents, standards and calibrators. In addition the sample size and reagent volumes in the sume reagens, bandards and valierers. Due to analyzer differences, the incubation time differs by approximately 15 seconds. Data from both platforms is used to file for 510(k).
3.7 Method Comparison
Substantial equivalence of the ACS and ADVIA Centaur Valproic acid assay to the predicate device is seen.
These correlation studies demonstrate that the ACS:180 & ADVIA Centaur Valproic acid assay is equivalent to each other as well as the predicate device.
| Reference
Assay | Test
Assay | Slope | Intercept | Correlation
Coefficient (r) | N |
|-----------------------|--------------------------------|-------|-----------|--------------------------------|-----|
| TDx valproic acid | ADVIA Centaur
Valproic acid | 0.96 | 4.03 | 0.99 | 250 |
| TDx valproic acid | ACS:180 Valproic
acid | 0.98 | 1.37 | 0.99 | 250 |
| ACS:180 Valproic acid | ADVIA Centaur
Valproic acid | 0.97 | 3.37 | 0.99 | 253 |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract, curved lines that resemble a human figure or a symbol representing health and well-being.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 9 2002
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarytown, NY 10591-5097
Re: K013959
Trade/Device Name: ADVIA Centaur and ACS: 180 Valproic Acid Assay Regulation Number: 21 CFR 862.3645; 21 CFR 862.3200 Regulation Name: Neuroleptic drugs radioreceptor assay test system; Clinical toxicology calibrator Regulatory Class: Class II; Class II Product Code: LEG: DKB Dated: November 29, 2001 Received: November 30, 2001
Dear Dr. Edds:
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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarketed This letter will anow you to begin maketing 5 our device of your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA inding of substantial equivalise of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and If you desire specific advice for your do rooms the Office of Complising of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the office of v additionally 809.10 for in viuo diagnostions on the promotion and advertising of your device, (301) 594-4588. Additionally, for questions on as prease note the regulation please contact the Office or Compliation and (1) rotification's (121CFR 807.97). Other general entitled, "Misbranding by relevence to promazion the Act may be obtained from the Division of Small information on your responsionals and Consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers International and Consumer Assistance at its toll-creation h Manufacturers International and Collisanter Filtp://www.fda.gov/cdrl/dsma/dsmamain.html".
(301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.htm
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _ Ko13959
of Page
Device Name: ADVIA Centaur and ACS:180 Valproic Acid Assay
Indications for Use:
The ACS:180 and ADVIA Centaur Valproic Acid Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of valproic acid in human serum and plasma for use on the automated analyzers marketed by Bayer Corporation. Valproic acid (2-propylpentanoic acid) is an anticonvulsant that is used alone or in combination with other anticonvulsant drugs to control seizures. Monitoring of valproic acid ensures that there is adequate drug in the blood stream without being at toxic levels. The ACS:180 and ADVIA Centaur Valproic Acid Immunoassays are used as an aid to monitor patients' valproic acid level.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) L OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109)
Bayer ADVIA Centaur and ACS:180 Valproic acid - 510(k) – Premarket notification