VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA

K973628 · Vital Scientific N.V. · JJF · Mar 13, 1998 · Clinical Chemistry

Device Facts

• Record ID: K973628
• Device Name: VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA
• Applicant: Vital Scientific N.V.
• Product Code: JJF · Clinical Chemistry
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2170
• Device Class: Class 1

Intended Use

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 Story

The Vitalab Flexor (also known as Selectra 2 or Viva) is a random-access, automated clinical micro-chemistry analyzer. It processes patient samples to measure analytes for clinical chemistry, drugs of abuse, and therapeutic drug monitoring. The system operates in a clinical laboratory setting, managed by laboratory technicians or clinicians. It supports multiple analytical modes: endpoint, kinetic with linearity check, bichromatic endpoint, two-point kinetic, and non-linear calibration. The device utilizes an optional ISE accessory for sodium, potassium, and chloride determination. Output consists of quantitative analyte measurements, which clinicians use to assess patient health, monitor drug levels, or screen for substance use. The system provides automated, high-throughput testing (up to 180 tests/hour) to assist in diagnostic decision-making.

Clinical Evidence

Bench testing only. Evaluation performed on 38 representative methods including clinical chemistry analytes (e.g., AST, ALT, Glucose, Creatinine), drugs of abuse (e.g., Benzodiazepine, Cocaine, Opiates), and therapeutic drugs (e.g., Cyclosporin, Carbamazepine). Data assessed precision, accuracy, linearity, and drift. Results demonstrated positive correlation and agreement with commercially marketed systems.

Technological Characteristics

Automated random-access micro-chemistry analyzer. Analytical modes: endpoint, kinetic, bichromatic endpoint, two-point kinetic, non-linear calibration. Throughput: up to 180 tests/hour. Optional ISE accessory for Na, K, Cl. No specific materials or software architecture standards provided.

Indications for Use

Indicated for clinical laboratory use to measure various analytes in clinical chemistry, drugs of abuse monitoring, and therapeutic drug monitoring. No specific patient population age or gender restrictions are stated.

Regulatory Classification

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.

Predicate Devices

• Roche Cobas Mira

Reference Devices

• AVL Scientific Corp. ISE unit

Submission Summary (Full Text)

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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:

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.

# 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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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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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.

(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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)