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.

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.

AI/ML Overview

The provided text describes the IMMAGE® Immunochemistry System Valproic Acid (VPA) Reagent and outlines the performance data used to demonstrate its safety and effectiveness. However, it does not explicitly state "acceptance criteria" in a quantitative manner or provide a detailed study report that proves the device meets specific, pre-defined acceptance criteria with quantifiable results.

The document primarily focuses on demonstrating "substantial equivalence" to a predicate device through method comparison, stability, and imprecision experiments, as required for a 510(k) submission. While performance data is presented, it's not structured as a direct comparison against a set of stated acceptance criteria.

Therefore, the following response will extract the available performance data and highlight the limitations in directly answering all parts of your request based on the provided text.

Here's the analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" against which the device's performance is measured. Instead, it presents performance data (Method Comparison and Imprecision) that are implicitly compared against the performance of the predicate device (Abbott TDx Valproic Acid Reagent) to demonstrate substantial equivalence.

Table: Available Performance Data (No Explicit Acceptance Criteria)

Performance Metric	Reported Device Performance (IMMAGE VPA Reagent)
Method Comparison	Data for "Method Comparison Study Results IMMAGE Valproic Acid (VPA) Reagent" is present but the formatting and content in the provided text is unreadable/corrupt (e.g., "American Car Call (11) Lampulanes...", "P. RAKERAE . Illust . Pres . busaneses ."). Therefore, specific values cannot be extracted. It states "Equivalence is demonstrated through method comparison..." implying favorable results against the predicate.
Imprecision	Data for "Estimated Imprecision" is present but the formatting and content in the provided text is unreadable/corrupt (e.g., "IN ANDRIGAL COLLER I SULLER BE...", "TEELLISELVIDE"). Values are noted under "Control . NE Automore and" and "evel". For example, "evel 3" shows "1 . 1 . 11 . 1 . 1 . 1 . 1 . 1". Therefore, specific values cannot be extracted.
Stability	"Equivalence is demonstrated through... stability... experiments." No specific data or acceptance criteria are provided in the extract.
Intended Use	Quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay.

2. Sample Size Used for the Test Set and Data Provenance

Due to the unreadable nature of the "Method Comparison Study Results" and "Estimated Imprecision" sections, specific sample sizes for these test sets cannot be determined from the provided text.

Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are implied to be internal validation studies conducted by Beckman Coulter, Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For an immunochemistry system that quantifies a substance in blood, the "ground truth" would typically be established by a reference method or a highly accurate gold standard assay, not by human expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth for this type of device is established by quantitative laboratory methods, not by expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

This information is not applicable. The device is an immunochemistry system for quantitative determination of valproic acid, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is described as an "Immunochemistry System Valproic Acid (VPA) Reagent" for use on the "IMMAGE® Immunochemistry Systems." This implies a standalone diagnostic test performed by the instrument. There is no mention of human interpretation being part of the primary assay result generation process. Therefore, the standalone performance is what is being reported (though specific values for method comparison and imprecision are unreadable).

7. The Type of Ground Truth Used

The ground truth for this type of quantitative assay would typically be established by:

Reference Method: Comparison against a widely accepted and highly accurate reference method (e.g., Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) for drug levels).
Predicate Device Comparison: As stated in the document, "Equivalence is demonstrated through method comparison, stability, and imprecision experiments," implicitly using the TDx® Valproic Acid (VPA) from Abbott Laboratories as a comparative "gold standard" or predicate for performance evaluation.

The document explicitly mentions a "Method Comparison Study" against the predicate device, suggesting the predicate device's results served as the comparative 'truth' in the context of demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This information is not provided in the document. For a traditional immunoassay system, there isn't a "training set" in the machine learning sense. The assay is developed and validated through laboratory experiments, calibration, and QC procedures.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the machine learning context for this device, this question is not applicable. The 'ground truth' for the development and validation of such a system would involve precise preparation of known concentration samples and characterization of reagents and system performance through a rigorous analytical chemistry process. Calibration is performed using "Beckman Drug Calibrator 1," which would have its concentrations established by a trusted reference method.

Summary

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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 SystemReagent	Predicate	Manufacturer	DocketNumber
IMMAGE SystemValproic Acid (VPA)	TDx®** Valproic Acid(VPA)	Abbott* Laboratories,Inc	K941615

*Abbott Laboratories, Abbott Park, IL 60064 **Trademark of Abbott Laboratories

5.0 Description:

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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 SystemVPA Reagent	Intended use.	Same as Abbott TDxValproic Acid Reagent
	Liquid stable reagents.
	Initial analytic ranges.
	DIFFERENCES
IMMAGE SystemVPA Reagent	IMMAGE utilizes nephelometricinhibition immunoassay	Abbott TDx reagents utilizefluorescence polarizationimmunoassay
	Antibody source for IMMAGEVPA is goat.	Antisera source for TDx valproicAcid is sheep.
	Calibration	IMMAGE VPA uses a singlepoint calibration while TDx ismultipoint.

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

American Car Call (11) Lampulanes ( California (1 (2006) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (P. RAKERAE . Illust . Pres . busaneses .... Кариз мочавтенера. A B S E S S S S S S S . C.	on annual color color de la program and a comprehensive of the contribution of the contribution of the contribution of the contribution of the contribution of the contributio/ RAY - A A B = A = A = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =.	Called of the production and control of the first and concessful proposed controlled inJECESSESSEDERS CORRES	Comments with Link July 1 Sep 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1..AAEAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA	FEFRANABEACHPAGELETTAFFERRARAGALERREEASE	September 4 18 8 8 10 10 10 10www.abababaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa.******************************************************************************************************************************************************************************. Каландина без беред часов с безде с в веканина в чиска седеренность с редакции

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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.

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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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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

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510(k) Number (if known): K981403

Device Name: IMMAGE® Immunochemistry System Valproic Acid (VPA) Reagent

Indications for Use:

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

Regulation Number and Section

§ 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.