(170 days)
Not Found
Not Found
No
The document describes a standard automated chemistry analyzer and does not mention any AI or ML components or functionalities.
No
The device is described as an in vitro diagnostic device (IVD) and an automated chemistry analyzer, used to measure analytes for diagnostic purposes, not to provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This notification is for an in vitro diagnostic device".
No
The device is described as an "automated chemistry analyzer" and a "Clinical Micro-Chemistry Analyzer," which are hardware devices used for laboratory testing. The description focuses on physical characteristics like throughput and random access capabilities, not solely on software functionality.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This notification is for an in vitro diagnostic device..."
- Function: The device is described as an "automated chemistry analyzer" intended "to measure a variety of analytes" in a clinical setting. This is a core function of IVD devices, which are used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Analytes Measured: The mention of measuring analytes in "clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring" further confirms its role in diagnostic and monitoring processes using biological samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JJF, CDN, CEM, CGA, DJC, DKZ, JGS, JXO, KLT, LAR, JRE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data for precision, accuracy, linearity and drift demonstrate general agreement with levels that are comparable to other systems presently being marketed commercially in the United States. The data demonstrate positive correlation and substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Roche Cobas Mira
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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.
3
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.
4
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 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
5
K973628 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
VITALAB FLEXOR Device Name:
Indications For Use:
- 17
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)