(21 days)
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No
The summary describes a standard immunoassay reagent and system for quantitative determination of valproic acid, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic (IVD) reagent used for the quantitative determination of valproic acid in human serum or plasma. It is used to measure a substance in the body, not to treat a condition or restore a function.
Yes
The device is intended for the quantitative determination of valproic acid in human serum or plasma, which is a measurement used in diagnosis and monitoring of medical conditions.
No
The device description clearly states it is a "Reagent" and is used "in conjunction with Beckman IMMAGE™ Immunochemistry Systems," indicating it is a chemical substance and part of a larger hardware system, not a standalone software product.
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 or plasma." This involves testing biological samples (serum or plasma) in vitro (outside the body) to diagnose or monitor a condition (in this case, likely related to valproic acid levels, which are often monitored for therapeutic drug management).
- Device Description: The description reinforces this by stating it's for "quantitative determination of valproic acid in human serum or plasma."
- Method: The method used is "rate nephelometric inhibition immunoassay," which is a common technique used in IVD testing.
- Predicate Device: The predicate device listed (TDx® Valproic Acid (VPA)) is also an IVD, further supporting the classification of this device as an IVD.
The core function of the device is to analyze a biological sample in vitro to provide information about a substance within that sample, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE® Immunochemistry System Valproic Acid (VPA) Reagent, when used in conjunction with Beckman IMMAGE® Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE® Immunochemistry Systems Drug Calibrator 1, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE Immunochemistry Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid test systems.
Product codes
DKB
Device Description
The IMMAGE Immunochemistry System VPA Reagent in conjunction with Beckman Drug Calibrator 1, is intended for use in the quantitative determination of valproic acid in human serum or plasma on Beckman Coulter's IMMAGE Immunochemistry Systems.
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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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
MAY - 8 1998
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5321
5981403
Summary of Safety & Effectiveness IMMAGE® Immunochemistry System Valproic Acid (VPA) Reagent
1.0 Submitted By:
Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123
2.0 Date Submitted:
April 16, 1998
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE® Immunochemistry System Valproic Acid (VPA) Reagent IMMAGE® Immunochemistry System Drug Calibrator 1
3.2 Classification Name
Valproic Acid (Not classified) Calibrator (21 CFR §862.3200)
4.0 Predicate Device(s):
| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|--------------------------------------|-------------------------------|------------------------------|------------------|
| IMMAGE System
Valproic Acid (VPA) | TDx®** Valproic Acid
(VPA) | Abbott* Laboratories,
Inc | K941615 |
*Abbott Laboratories, Abbott Park, IL 60064 **Trademark of Abbott Laboratories
5.0 Description:
The IMMAGE Immunochemistry System VPA Reagent in conjunction with Beckman Drug Calibrator 1, is intended for use in the quantitative determination of valproic acid in human serum or plasma on Beckman Coulter's IMMAGE Immunochemistry Systems.
1
Beckman Coulter, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Valproic Acid (VPA) Reagent Summary of Safety & Effectiveness
Intended Use: 6.0
The IMMAGE® Immunochemistry System Valproic Acid (VPA) Reagent, when used in conjunction with Beckman IMMAGE® Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE® Immunochemistry Systems Drug Calibrator 1, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE Immunochemistry Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid test systems.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時
| SIMILARITIES | ||
|---|---|---|
| IMMAGE System | ||
| VPA Reagent | Intended use. | Same as Abbott TDx |
| Valproic Acid Reagent | ||
| Liquid stable reagents. | ||
| Initial analytic ranges. | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| VPA Reagent | IMMAGE utilizes nephelometric | |
| inhibition immunoassay | Abbott TDx reagents utilize | |
| fluorescence polarization | ||
| immunoassay | ||
| Antibody source for IMMAGE | ||
| VPA is goat. | Antisera source for TDx valproic | |
| Acid is sheep. | ||
| Calibration | IMMAGE VPA uses a single | |
| point calibration while TDx is | ||
| multipoint. |
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments.
Method Comparison Study Results IMMAGE Valproic Acid (VPA) Reagent
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This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The text "USA" is included as part of the seal.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 8 1998
Annette Hellie . Senior Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-337 P.O. Box 8000 Brea, California 92822-8000
K981403 Re : IMMAGE® System Valproic Acid (VPA) Reagent Requlatory Class: II Product Code: DKB Dated: April 16, 1998 Received: April 17, 1998
Dear Ms. Hellie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination-assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Butman
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): K981403
Device Name: IMMAGE® Immunochemistry System Valproic Acid (VPA) Reagent
Indications for Use:
The IMMAGE Immunochemistry System Valproic Acid (VPA) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay.
Clinical Significance:
Valproic acid is an anti-convulsant indicated for use as sole and adjunctive therapy in the treatment of petit mal and multiple seizure types, which include complex absence seizures. The test is used to monitor the level of valproic acid in the blood to ensure that proper therapeutic levels are maintained and that the concentration remains below the level where hepatotoxicity may occur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96
Veronice J. Palmer for AW Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981403