(238 days)
The Quatro SP Series Robotic Sample Processing Systems and their accessories are provided as generic liquid handling systems which must be customized and validated for each user environment, according to in vitro diagnostic test instructions and requirements. The customization can be accomplished by users or can be provided, to customer specifications, by Zenyx authorized representatives.
Quatro SP Series Sample Processing Systems are bench top, four probe, automated pipettor/dilutors of various sizes (capacities) which are programmed via keypad or personal computer. Optional system components include bar code readers, sample racks for tubes or microplates, workstations, and a washing module. Another option, Concerto software, allows control of the processor from a personal computer and extension of programming capabilities via menu-driven commands. The Quatro SP Series Sample Processing Systems use either stainless steel or teflon coated probe tips. The systems are supplied for generic liquid handing application and must be customized to each user's in vitro test specifications. Training is provided for users who wish to perform their own programming.
Here's an analysis of the provided text, focusing on acceptance criteria and a study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy at 10 µL | +/- 1% at 10 µL |
| Overall Coefficient of Variation (CV) | Less than 1% under a standard protocol |
| Carryover of liquids | Variable and influenced by type of probe tip, assay setting, sample processor model, and nature of samples tested. Zenyx experts can assist in minimizing it. Each user must validate satisfactory carryover for each test protocol. (This indicates that while carryover is acknowledged, the specific quantitative acceptance for this is user-defined and not universally stated as a fixed benchmark by the manufacturer in this document.) |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Each instrument is tested for accuracy and precision." This implies that the testing is performed on individual manufactured units of the device.
- Sample Size for Test Set: Implicitly, each instrument manufactured is tested. The text does not provide a specific number for a dedicated test set used for the regulatory submission beyond the "each instrument" statement.
- Data Provenance: The testing is conducted by the manufacturer, Zenyx Scientific Ltd. The document suggests this is part of their quality control and manufacturing process. There is no information regarding the country of origin of this specific test data, nor is it explicitly stated as retrospective or prospective data. However, given it's part of instrument testing before shipment, it would be considered prospective for each individual instrument.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The "ground truth" for accuracy and precision is based on gravimetric testing and calculation of Coefficient of Variation, which are objective, quantifiable measurements. It does not rely on expert subjective assessment.
- Qualifications of Experts: Not applicable for establishing ground truth in this context. The document mentions "Zenyx liquid handling experts" who "can assist customers in minimizing carryover," but these are for customer support and not for establishing the fundamental performance (accuracy/precision) ground truth for the regulatory submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As the ground truth is established through objective, quantitative measurements (gravimetric testing, CV calculation), there is no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. This device is an automated pipetting and diluting system. MRMC studies are typically performed for diagnostic imaging devices or other technologies where human interpretation is involved and subject to variability. This document describes a purely automated system with objective performance metrics.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes. The performance data presented (accuracy and precision) directly reflects the standalone performance of the Quatro SP Series Sample Processing Systems as an automated device, without human intervention during the liquid handling process itself. The "human-in-the-loop" aspect comes in programming and validating the system, but the core performance metrics are for the automated function.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for accuracy and precision is based on objective quantitative measurements using gravimetric testing (for accuracy) and statistical calculations (for CV/precision). For carryover, the principle is also objective, but the acceptable level is defined by the user for their specific assays.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable in the traditional sense of a machine learning model. This is a robotic hardware system, not an AI or algorithm that "learns" from a training set. Its operational parameters are programmed rather than learned through data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. See point 8. The device's operation is based on its mechanical design, software programming, and calibrated components, not on a data-driven training process.
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APR 3 0 1998
August 28, 1997 Date:
Zenyx Scientific Ltd. Sponsor: Broadoak Business Centre Ashburton Road West, Trafford Park Manchester, UK M17 1RW
Paul W. McWalter Contact:
Tel: 011 44 161 848-0300 Fax: 011 44 161 848-0157
Proprietary Names: Quatro SP Sample Processing Systems Quatro Concerto Software
Classification Name: Automated Pipetting and Diluting System
Common Name: Robotic Sample Processor
Predicate Device: Novapath SP Advanced Liquid Handling System, which is the Quatro SP 200D, manufactured under OEM arrangement for Bio-Rad Laboratories. The Novapath included a microplate reader with computer interface. This sample processing system was cleared for US marketing on March 9, 1990 under reference number K900775. The differences in the Quatro 200D and other SP Series models involve workstation capacity for handling tubes and microplates, physical dimensions, keypad control option, and bar code reader option. All Quatro SP models are identical to the Novapath in principles of operation, intended use, power requirements and consumption, and most functional and technical specifications.
Device Description: Quatro SP Series Sample Processing Systems are bench top, four probe, automated pipettor/dilutors of various sizes (capacities) which are programmed via keypad or personal computer. Optional system components include bar code readers, sample racks for tubes or microplates, workstations, and a washing module. Another option, Concerto software, allows control of the processor from a personal computer and extension of programming capabilities via menu-driven commands. The Quatro SP Series Sample Processing Systems use either stainless steel or teflon coated probe tips. The systems are supplied for generic liquid handing application and must be customized to each user's in vitro test specifications. Training is provided for users who wish to perform their own programming. When
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Zenyx supplies customized software with the sample processing system, a user validation quide is included.
Intended Use: Liquid handling and sample preparation for in vitro diagnostic testing in the clinical laboratory.
Performance Data: Each instrument is tested for accuracy and precision. A gravimetric test must yield +/- 1% at 10 µl. Overall CV must be less than 1% under a standard protocol. These results are reported on Instrument Test Certificates which are issued with each system. Carryover of liquids is variable and is influenced by type of probe tip, assay setting, sample processor model, and the nature of samples tested. Zenyx liquid handling experts can assist customers in minimizing carryover, if it is a concern. Each user must validate that the unit has been programmed to local test specifications and that the accuracy, precision and carryover are satisfactory for each test protocol.
Conclusion: Approximately 450 Quatro SP series sample processing systems have been placed successfully in 25 countries over the past decade. An estimated one million clinical assays are performed annually, with approximately 10% of these performed in the US.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 3 0 1998
Mr. Paul McWalter
- Requlatory Affairs Manager Zenvx Scientific Ltd Barnes Hospital Cheadle Cheshire SK8 2NY United Kingdom
RE: K973335 Trade Name: Quatro SP Series Robotic Sample Processing Systems, Models 200-499, Sample Transport Unit/Automated Security Module and Quatro Concerto Software Regulatory Class: I Product Code: JQW Received: April 16, 1998 April 9, 1998 Dated:
Dear Mr. McWalter:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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, Druq, and Cosmetic Act (Act). 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸਿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 at (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number:
Device Name:
Quatro SP Series Robotic Sample Processing Systems, Models 200 - 499, inclusive Sample Transport Unit or Automated Sample Security Module Quatro Concerto Software
Indications for Use:
The Quatro SP Series Robotic Sample Processing Systems and their accessories are provided as generic liquid handling systems which must be customized and validated for each user environment, according to in vitro diagnostic test instructions and requirements. The customization can be accomplished by users or can be provided, to customer specifications, by Zenyx authorized representatives.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device. Evaluation (ODE) . . . . . .
Clion Maria
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K47335
Prescription Use
(Per 21 CFR 801.109) /
OR
Over-The-Counter Use
§ 862.2750 Pipetting and diluting system for clinical use.
(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(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.