(31 days)
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No
The document describes a quality control material for laboratory testing and does not mention any AI or ML components.
No
This device is a quality control material intended to monitor the performance of laboratory testing procedures (in vitro diagnostic use), not to treat, diagnose, cure, or prevent disease in a patient.
No
The device is a quality control material intended to monitor the performance of laboratory testing procedures, not to diagnose a patient. It is used in conjunction with diagnostic devices.
No
The device is a liquid control material prepared from human red cells, clearly indicating it is a physical substance and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The controls are for in vitro diagnostic use only".
- Purpose: The device is intended to "monitor the performance of laboratory testing procedures for HbA1c quantitation." This is a classic function of an IVD, which is used to test samples taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description mentions it's "prepared from human red cells" and "should be treated the same as patient specimens and tested following the instructions included with the instrument, kit or reagent being used." This further reinforces its use in a laboratory setting for analyzing human samples.
- Quality Control Material: The device is described as a "quality control material," which is a type of IVD used to ensure the accuracy and reliability of diagnostic tests.
Therefore, based on the provided information, this device fits the definition and intended use of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Liquid Stable HbA1c Control is intended for use as a quality control material to monitor the performance of laboratory testing procedures for HbA1c quantitation. The control is designed for use with lon exchange HPLC assays, Immunoassay based assays and Boronate Affinity based assays.
Product codes
JJX
Device Description
The Liquid Stable HbA1c Control is a bi-level liquid HbA1c control that is prepared from human red cells. The control should be treated the same as patient specimens and tested following the instructions included with the instrument, kit or reagent being used.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies at 20° - 25°C were performed on the Bio-Rad Variant, Bayer DCA200, Roche Hitachi 917 and Primus CLC385 to validate the open vial stability claims. Real-time studies were performed on the Bayer DCA2000 and BioRad Variant at 2°-8°C. The results support a shelf life at 2°-8°C of 18 months and an open vial claim of 30 days (at 2°-8°C).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Quantimetrix Corporation, GlycoHemosure. (510(k) # K032791)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Section 11 510(k) Device Summary
Image /page/0/Picture/2 description: The image shows the logo for Canterbury Scientific Ltd. The logo features the word "Canterbury" stacked on top of the word "Scientific", with "Ltd" in a smaller font size to the right of "Scientific". To the left of the text is a stylized graphic that resembles a laboratory flask or beaker.
14 Pope Street, Christchurch, NEW ZEALAND Phone +64 3 343 3345 FAX +64 3 343 3342
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is ________________________________________________________________________________________________________________________________________________ K043070
| Submitter | Canterbury Scientific Ltd
14 Pope Street
Christchurch
New Zealand
Phone +64 3 343 3345
FAX +64 3 343 3342 |
|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person
Date of Preparation
Device Name
Common Name
Classification
Class
Product Code
Equivalent Device | Maurice Owen, PhD, Scientific Director
November 2, 2004
Liquid Stable HbA1c Control
HbA1c Controls
21CFR 862.1660 Quality Control Material (assayed and
unassayed)
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JJX
Quantimetrix Corporation, GlycoHemosure. (510(k) # K032791) |
| Description of Device | The Liquid Stable HbA1c Control is a bi-level liquid HbA1c
control that is prepared from human red cells. The control
should be treated the same as patient specimens and tested
following the instructions included with the instrument, kit or
reagent being used. |
| Intended Use of Device | The Liquid Stable HbA1c Control is intended for use as a quality
control material to monitor the performance of laboratory testing
procedures for HbA1c quantitation. The control is designed for
use with lon exchange HPLC assays, Immunoassay based
assays and Boronate Affinity based assays. |
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practices. The two levels of controls allow performance monitoring within the clinical range.
The controls are for in vitro diagnostic use only and should not be used past the expiry date.
Comparison with Predicate Device
The Canterbury Scientific Ltd Liquid Stable HbA1c Control is substantially equivalent to Glycohemosure HbA1c Control manufactured by Quantimetrix Corporation. They both have the same intended application and technical characteristics.
Canterbury Scientific Ltd Liquid Stable HbA1c Control has an open vial stability of 30 days at 2°-8°C, the same as Quantimetrix's Glycohemosure. The closed vial stabilities are also identical at 18 months at 2° - 8°C.
Performance Characteristics
Stability studies at 20° - 25°C were performed on the Bio-Rad Variant, Bayer DCA200, Roche Hitachi 917 and Primus CLC385 to validate the open vial stability claims. Real-time studies were performed on the Bayer DCA2000 and BioRad Variant at 2°-8°C. The results support a shelf life at 2°-8°C of 18 months and an open vial claim of 30 days (at 2°-8°C).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected, flowing lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 9 2004
Maurice Owen, PhD Scientific Director Canterbury Scientific Ltd 14 Pope Street Christchurch 8001 New Zealand
Re: K043070
Trade/Device Name: Liquid Stable HbA1c Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: November 3, 2004 Received: November 8, 2004
Dear Dr. Owen :
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 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 vours,
Cornelia B. Lorks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K043070
Device Name: Liquid Stable HbA1c Control
Indications for Use:
The Liquid Stable Hemoglobin A1c Control is intended for use as a quality control material to monitor the performance of laboratory testing procedures for HbA1c quantitation. The control is designed for use with lon exchange HPLC assays, Immunoassay based analyses and Boronate Affinity based assays.
The use of quality control materials is indicated as an objective assessment of the precision and bias of methods and techniques in use and is an integral part of good laboratory practices. The two levels of controls allow performance monitoring within the clinical range.
The controls are for in vitro diagnostic use only and should not be used past the expiry date.
V Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
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