This notification is for an in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

Device Description

A random access, automated Clinical Micro-Chemistry Analyzer with a throughput of up to 180 test per hour which is intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry. monitoring drugs of abuse and in therapeutic drug monitoring.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Vitalab Flexor Clinical Laboratory Analysis and Reagent System, asserting its substantial equivalence to the Roche Cobas Mira. The document focuses on demonstrating comparable performance through various analytical modes for a range of analytes.

Here's an analysis of the acceptance criteria and the study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative "acceptance criteria" in the format of specific thresholds (e.g., "accuracy > 95%"). Instead, it states that the device's performance "demonstrates general agreement with levels that are comparable to other systems presently being marketed commercially in the United States" and shows "positive correlation and substantial equivalence" to the predicate device.

The reported device performance is qualitative in nature, emphasizing comparability rather than meeting pre-defined numerical targets.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision	Comparable to commercially marketed systems	Demonstrates general agreement with comparable levels
Accuracy	Comparable to commercially marketed systems	Demonstrates general agreement with comparable levels
Linearity	Comparable to commercially marketed systems	Demonstrates general agreement with comparable levels
Drift	Comparable to commercially marketed systems	Demonstrates general agreement with comparable levels
Correlation	Positive correlation with predicate device	Data demonstrates positive correlation and substantial equivalence
Analytical Modes	Accommodate various analytical modes (endpoint, kinetic, bichromatic, two-point kinetic, non-linear calibration)	Evaluated methods include these modes.

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

Sample Size for Test Set: The document mentions "data on twenty-nine (29) representative Clinical Chemistry analytes," "seven (7) representative analytes for Drugs of Abuse," and "two (2) representative analytes for therapeutic drug monitoring." Additionally, it states "Thirty-eight (38) representative methods were selected for evaluation." The exact number of individual samples (patients or controls) analyzed for each analyte or method is not specified. It refers to analytes/methods as the units of evaluation, not individual patient samples.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that the manufacturer is based in the Netherlands and has a USA branch, the studies could have been conducted in either location or a combination. The submission is for marketing in the United States.

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

This information is not provided in the document. The study appears to be a technical validation of an in-vitro diagnostic device assessing its analytical performance against a predicate device, rather than a clinical study requiring expert interpretation of diagnostic outcomes. Ground truth for chemical analytes would typically be established by established reference methods, not expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. As noted above, the evaluation is a technical comparison of an in-vitro diagnostic device's analytical performance against a predicate, not a clinical study involving human interpretation that would require 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated in-vitro diagnostic chemistry analyzer, meaning it performs chemical analysis of biological samples without direct human-in-the-loop interpretation of visual or complex data that would involve "readers" in the context of an MRMC study. The concept of "human readers improve with AI" is not relevant to this type of device.

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

The device itself is an automated system (algorithm only). The performance data presented (precision, accuracy, linearity, drift) specifically represents the standalone performance of the Vitalab Flexor system in processing samples and measuring analytes. Without a human in the loop, this is a standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth used for this type of device is implicitly based on:

Reference Methods/Predicate Device: The performance is compared to "levels that are comparable to other systems presently being marketed commercially in the United States," specifically stating that the Vitalab Flexor is "substantially equivalent to the Roche Cobas Mira." Therefore, the predicate device (Roche Cobas Mira) itself, validated through its own established analytical performance, serves as a de facto "ground truth" or standard for comparison.
Established Analytical Principles: The evaluation of precision, accuracy, linearity, and drift relies on established analytical principles and statistical methods commonly applied in clinical chemistry. These are fundamental measures of analytical performance, where "ground truth" would be the true value of an analyte as determined by highly accurate reference methods, or the expected range given a control material.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. The Vitalab Flexor is a traditional clinical chemistry analyzer, not a machine learning or AI-driven system that requires a "training set" in the conventional sense of supervised learning. Its operational parameters and calibration are established through manufacturers' protocols and reference materials, not through a large dataset of labeled training examples.

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

This information is not applicable for the reasons stated in point 8.

Summary

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K9736028

VITAL MAR 1 3 1998

USA: One Gateway Center, Suite 415 New

nsselaenvers 4 Spankers

September 19, 1997

Premarket Notification [510(k)] Summary

for the VITALAB FLEXOR Clinical Laboratory Analysis and Reagent System

Device Name:

Vitalab Flexor (In-vitro diagnostic system). The Vitalab Flexor is also tradenamed the Vitalab Selectra 2 and the Vitalab Viva. References in this document submission may use either of the two names interchangeably.

Common Name:

Automated chemistry analyzer, micro, for clinical use.

Classification Name:

Analyzer, chemistry, micro, for clinical use - has been classified as Class I devices, as per 21 CFR 862.2170. This device is intended for clinical use in conjunction with certain materials to measure a variety of analytes.

Establishment Registration:

Vital Scientific NV, a company established under the laws of the Netherlands, with headquarters at van Rensselaerweg 4, Spankeren, 6956 AV, The Netherlands and with a USA branch office located at One Gateway Center, Suite 415, Newton, MA 02158. Vital Scientific is a registered as a medical device manufacturer under files number 8030478. All instruments are manufactured in the Netherlands. Contact person: Israel M. Stein MD.

Performance Standards:

There are no performance standards for these devices.

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Labeling:

This device is labeled in accordance with 21 CFR 809.10.

Summary description of device:

Substantial Equivalence:

The Vitalab Flexor System is substantially equivalent to the Roche Cobas Mira presently in distribution in the United States. The Vitalab Flexor System has the same technological characteristics and intended use as these systems. These systems are automated micro-chemistry analyzers intended for clinical use in conjunction with certain materials to measure a variety of analytes (21 CFR 862.2170).

We are including data on twenty-nine (29) representative Clinical Chemistry analytes manufactured by Trace Scientific Pty. Ltd., seven (7) representative analytes for Drugs of Abuse manufactured by Behring Diagnostics and two (2) representative analytes for therapeutic drug monitoring, manufactured by Behring Diagnostics. All of these analytes are presently 510(k) approved under separate submissions by their respective companies. These analytes were chosen because thev are representative of the reaction types to be processed on the analyzer.

Thirty-eight (38) representative methods were selected for evaluation including Acid Phosphatase, Alkaline Phosphatase, Albumin, ALT, Amylase, AST, Bicarbonate, Direct Bilirubin, Total Bilirubin, Calcium, Chloride, Creatinine Kinase, Creatinine, Gamma GT, Glucose, Inorganic Phosphate, Iron, LDH, Magnesium, Total Protein, Triglycerides, Uric Acid, Benzodiazepine, Cocaine, Opiate, Amphetamine, Methadone, THC, Cyclosporin, and Carbamazepine. These include the following analytical modes: endpoint, kinetic with linearity check, bichromatic endpoint, two-point kinetic, and non-linear calibration curve.

The data for precision, accuracy, linearity and drift demonstrate general agreement with levels that are comparable to other systems presently being

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marketed commercially in the United States. The data demonstrate positive correlation and substantial equivalence.

The optional Vitalab ISE accessory for the determination of Sodium, Potassium, and Chloride is manufactured by AVL Scientific Corp. This unit is essentially equivalent to other ISE units marketed by AVL in the United States.

Vital Scientific NV, submits that the Vitalab Flexor System has clinically acceptable performance comparable to similar devices currently in commercial distribution. These data provide scientific evidence of equivalency for Vitalab Flexor System. The data indicates a positive correlation, and therefore, is substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 3 1998

Israel M. Stein, M.D. Managing Director Vital Scientific One Gateway Center, Suite 415 Newton, Massachusetts 02158

K973628 Re : VITALAB FLEXOR Analyzer Regulatory Class: II Product Code: JJF, CDN, CEM, CGA, DJC, DKZ, JGS, JXO, KLT, LAR, JRE Dated: January 30, 1998 February 2, 1998 Received:

Dear Dr. Stein:

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 qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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. ਉ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: 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 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

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K973628 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

VITALAB FLEXOR Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1973628

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.2170 Micro chemistry analyzer for clinical use.

(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.