Valproic Acid (VPA) Reagent, in conjunction with the SYNCHRON® Systems Drug Calibrator 1 set, is intended for the quantitative determination of valproic acid concentration in human serum or plasma on SYNCHRON Systems.

Valproic Acid is an anticonvulsant drug. It is indicated for the treatment of absence (petite mal), generalized tonic-clinic and myoclonic seizures. Valproic Acid therapy is monitored for suspected inadequate dose or toxicity.

Valproic Acid Reagent is used to measure the valproic acid concentration by a particle enhanced turbidimetric inhibition immunoassay method.

Device Description

The SYNCHRON Systems VPA Reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4A/4PRO. CX5/5CE/5A/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO) and SYNCHRON LX (LX20/PRO/LXi) Systems. The reagent kit contains two 100-test cartridges, and is packaged separately from the associated calibrators.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: SYNCHRON® Systems Valproic Acid Reagent. This document is a regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the level of detail regarding device performance studies, acceptance criteria, and ground truth establishment typically found in a research paper or a more comprehensive study report.

Based on the information provided, here's what can be extracted and what is explicitly not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states "updated performance claims (equivalency, precision) in the product inserts" and "Performance data from validation testing supports equivalency." However, it does not provide a specific table of acceptance criteria or detailed results of device performance against such criteria. It implies that these details would be found in the product inserts.

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

The document mentions "validation testing" but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided. For clinical chemistry assays like valproic acid, "ground truth" is typically established by reference methods or validated laboratory measurements, not by expert consensus in the same way it would be for imaging diagnostics.

4. Adjudication Method for the Test Set:

This information is not applicable or provided. Adjudication methods are usually relevant for expert-based assessments, not for quantitative chemical assays where measurements are compared to reference standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC studies are primarily relevant for diagnostic imaging interpretation or other scenarios involving human readers. This is a chemical reagent for a laboratory instrument, so an MRMC study is not applicable and therefore not mentioned.

6. Standalone Performance Study:

The document implies standalone performance testing as part of "validation testing" and updating "performance claims" (equivalency, precision). However, it does not detail the specifics of such a study, including its design or explicit results that would constitute "standalone performance." It primarily focuses on demonstrating equivalence to the previous version of the device rather than a ground-up standalone evaluation documented here.

7. Type of Ground Truth Used:

For this type of device (a quantitative reagent for valproic acid), the "ground truth" would typically be established by a reference method for valproic acid measurement, or by comparing results to a legally marketed predicate device (which is explicitly what this 510(k) references and compares against). The document states the modification "claims substantial equivalence to the Beckman Coulter SYNCHRON Systems VPA Reagent currently in commercial distribution, FDA 510(k) Number K961256." This comparison to a predicate device serves as the basis for establishing performance and "ground truth" in the context of a 510(k). No pathology or outcomes data is mentioned as ground truth.

8. Sample Size for the Training Set:

This information is not explicitly provided. For chemical reagents, "training sets" are not typically discussed in the same way as for machine learning algorithms. Instead, method development and optimization would involve various samples, but a specific "training set" size isn't usually reported in this context.

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

This information is not provided or applicable as "training set" ground truth in a machine learning sense. The "ground truth" for optimizing the reagent (if one were to call it a training phase) would involve comparing early formulations' results against a reference method or established values for known samples.

In summary:

This document is a regulatory submission focused on substantiating equivalence due to a modification of an already legally marketed device. It does not provide the detailed scientific study report typically associated with demonstrating performance against specific acceptance criteria for a novel device. The core of the submission is the "Comparison to the Predicate" based on an "ingredient change to the reagent formulation, optimization of the operating parameters on the LX instrument platform, and updated performance claims (equivalency, precision) in the product inserts." The study proving the device meets acceptance criteria is implied to be the "validation testing" that "supports equivalency," but the specifics of that testing are not included in this summary.

Table: Acceptance Criteria and Reported Device Performance (Based on available information)

Acceptance Criteria Category	Specific Criteria (Not detailed in document)	Reported Device Performance
Equivalency	Implied to be equivalent to predicate device (K961256) for quantitative determination of valproic acid.	"Performance data from validation testing supports equivalency."
Precision	"Updated performance claims" in product inserts.	"Updated performance claims" in product inserts.
Intended Use	Quantitative determination of valproic acid in human serum or plasma.	Device functions for its intended use as described.

Missing Information:

Sample sizes for any testing.
Data provenance (country, retrospective/prospective).
Number and qualifications of experts for ground truth (not applicable for this device type).
Adjudication method (not applicable for this device type).
MRMC study (not applicable for this device type).
Detailed standalone performance results (beyond a general statement of "equivalency" and "updated claims").
Specific, quantifiable acceptance criteria for equivalency and precision.
Details on ground truth establishment for "validation testing" samples (e.g., specific reference method used).
Training set size and ground truth establishment (not explicitly applicable for this type of device development).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with a white wave-like design inside, followed by the company name "BECKMAN COULTER" in bold, sans-serif font. The text is arranged in two lines, with "BECKMAN" on the top line and "COULTER" on the bottom line.

510(k) Summary

JUL 1 5 2003

1.0 Submitted By:

Mary Beth Tanq Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123

2.0 Date Submitted

June 16, 2003

3.0 Device Name(s):

3.1 Proprietary Names
SYNCHRON® Systems Valproic Acid Reagent
3.2 Classification Names
Neuroleptic drugs radioreceptor assay test system (21 CFR § 862.3645)

4.0 Legally Marketed Device

The SYNCHRON Systems Valproic Acid (VPA) Reagent claims substantial equivalence to the Beckman Coulter SYNCHRON Systems VPA Reagent currently in commercial distribution, FDA 510(k) Number K961256.

5.0 Device Description

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON Systems Valproic Acid Reagent File: VPA_s510k.doc 6/03

Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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6.0 Intended Use

7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)

The modification to the SYNCHRON Systems VPA assay involves a non-reactive ingredient change to the reagent formulation, optimization of the operating parameters on the LX (LX20/PRO/LXi) instrument platform, and updated performance claims (equivalency, precision) in the product inserts.

8.0 Summary of Performance Data

Performance data from validation testing supports equivalency.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle or bird-like symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The seal is presented in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 15 2003

Ms. Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., - M/S W-104 Box 8000 Brea, CA 92822-8000

Re: K031870

Trade/Device Name: SYNCHRON® Systems Valproic Acid Reagent Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: LEG Dated: June 16, 2003 Received: June 17, 2003

Dear Ms. Tang:

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 i 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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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page 1 of 1

510(k) Number (if known): To be assigned

Made with FlippingBook

K031870

SYNCHRON® Systems Valproic Acid Reagent Device Name:

Indications for Use:

Valproic Acid Reagent is used to measure the valproic acid concentration by a particle enhanced turbidimetric inhibition immunoassay method.

(b) Classification. Class II.

(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

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K031870

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON Systems Valproic Acid Reagent File: VPA s510k.doc 6/03

Regulation Number and Section

§ 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.