(65 days)
For in vitro diagnostic use only. The extendSURE™ lyophilized hemoglobin A1c linearity controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.
The extendSURE™ Lyophilized Hemoglobin A1c Linearity Controls comprises one vial each of 5 equally spaced levels of HbA1c control, 1 vial of reconstitution fluid and a product information sheet. The product is provided in a lyophilized form and each vial is reconstituted with 0.25 mL of reconstitution fluid (0.09% sodium azide) prior to use.
Here's a summary of the acceptance criteria and the study details for the extendSURE™ Lyophilized Hemoglobin A1c Linearity Controls, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | To verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories. |
| Stability (Closed Vial) | 36 months at 2° to 8°C. |
| Stability (Open Vial - Reconstituted) | 7 days at 2° to 8°C. |
| Compatibility | Suitable for use on Bayer DCA 2000, BioRad Variant Classic (with HbA1c program), Olympus AU Series, and Primus CLC 385. |
| Range | Covers a similar range of about 4 - 18% HbA1c (NGSP aligned), similar to the predicate device. |
| Number of Levels | 5 levels of HbA1c control. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of typical AI/ML device validation where a distinct, prospectively collected, or independently curated dataset is used to evaluate the final performance of an algorithm against ground truth.
Instead, the performance characteristics are related to stability studies, which involve testing the device itself over time on various laboratory instruments.
- Sample Size: The document does not specify the number of individual control vials or measurements used in the stability studies. It simply mentions "Stability studies...were performed."
- Data Provenance: The studies were conducted by Canterbury Scientific Ltd. It's an internal study presumably performed in New Zealand based on the company's location. The data is retrospective in the sense that the stability studies were completed and then reported for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a linearity control, not an AI/ML algorithm that generates a diagnostic output requiring expert interpretation for ground truth. The "ground truth" here is the chemical stability and performance of the control material itself when measured by laboratory instruments. The "truth" is established by the known concentration ranges of HbA1c in the control material and its linearity when tested on specific instruments.
4. Adjudication Method for the Test Set
Not applicable, for the same reasons as above.
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
Not applicable. This is not an AI/ML diagnostic aid. It is a quality control material.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The ground truth used for evaluating the performance of the linearity controls is:
- Analytical Performance: The inherent chemical stability of the HbA1c levels within the control material over time and under various storage conditions.
- Instrument Measurements: The ability of the control material to demonstrate linearity when measured by established and validated laboratory instruments (e.g., Bayer DCA 2000, BioRad Variant Classic). The "truth" is whether the measured values on these instruments fall within expected ranges and demonstrate
linearity across the specified range.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as above. The "ground truth" for the linearity controls themselves is established during their manufacturing process, where specific concentrations of HbA1c are formulated, and then confirmed through extensive stability and performance testing against known analytical methods on various laboratory platforms.
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Section 11 510(k) Device Summary
Image /page/0/Picture/2 description: The image shows the logo for Canterbury Scientific. The logo consists of a black circle with a white flask inside on the left. To the right of the circle is the text "CANTERBURY SCIENTIFIC" in black, with the website address "www.canterburyscientific.com" below.
AUG 2 2 2007
Canterbury Scientific Ltd 14 Pope Street, Christchurch, NEW ZEALAND Phone +64 3 343 3345 FAX +64 3 343 3342 csl@canterburyscientific.com
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 _140211048
| Submitter | Canterbury Scientific Ltd14 Pope StreetChristchurch, 8011New ZealandPhone +64 3 343 3345FAX +64 3 343 3342 | |||
|---|---|---|---|---|
| Contact Person | Maurice Owen, PhD, FACB, Scientific DirectorPhone +643 343 3345Fax +643 343 3342Email mowen@canterburyscientific.com | |||
| Establishment Registration Numbers | Registration NumberOwner/Operator Number | 30039826019051098 | ||
| Date of Preparation | May 22, 2007 | |||
| Device Name | extendSURE™ Lyophilized Hemoglobin A1c Linearity Controls | |||
| Common Name | Glycated Hemoglobin A1c Linearity Controls | |||
| Classification | 21CFR 862.1660 Quality Control Material (assayed andunassayed) | |||
| Class | I | |||
| Product Code | JJX | |||
| Predicative Device | Company NameBrand Name | Bio-Rad Laboratories,Lyphochek® Hemoglobin A1c LinearitySet Levels 1, 2, 3 and 4K003030GGM | ||
| 510(k) NumberProduct Code | ||||
| Description of Device | The extendSURE™ Lyophilized Hemoglobin A1c LinearityControls comprises one vial each of 5 equally spaced levels ofHbA1c control, 1 vial of reconstitution fluid and a productinformation sheet. |
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Ko 71648
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page 36 of 36
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The product is provided in a lyophilized form and each vial is reconstituted with 0.25 mL of reconstitution fluid (0.09% sodium azide) prior to use.
The extendSURE™ Iyophilized hemoglobin A1c linearity Intended Use of Device controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.
The control is for in vitro diagnostic use only and should not be used past the expiry date.
Comparison with Predicate Device
The device (extendSURE™ Iyophilized HbA1c Linearity Controls) shows substantial equivalence to device K003030 (BioRad Lyphochek® Hemoglobin A1c Linearity Set) in terms of intended use to verify the linearity of HbA1c assays across the patient reportable range using protocols established in individual laboratories. Both products are produced from human whole blood and are lyophilized for long term closed vial stability. Both cover a similar range of about 4 - 18% HbA1c (NGSP aligned).
The new devise (extendSURE™ Lyophilized HbA1c Linearity Controls) has 5 levels compared to the 4 in the predicate device.
Performance Characteristics
Stability studies at 2° to 8°C were performed on the Bayer DCA 2000 and the BioRad Variant Classic with the Hemoqlobin A1c program. The results support a shelf life (closed vial) at 2° to 8°C of 36 months from the date of manufacture and an open vial (reconstituted) life of 7 days at 2° to 8°C.
The device is also suitable for use on the following Instruments; Olympus AU Series and Primus CLC 385.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 2 2007
Canterbury Scientific Ltd. c/o Maurice Owen, Ph.D. Scientific Director 14 Pope Street, Riccarton Christchurch, Canterbury 8011 New Zealand
Re: K071648 Trade/Device Name: extendSURE™ Lyophilized Hemoglobin A1c Linearity Controls Regulation Number: 21 CFR$862.1660 Regulation Name: Quality control material Regulatory Class: Class I Product Code: JJX Dated: July 26, 2007 Received: July 30, 2007
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Coopers, M.S., D.V.M.
Séan M. Cooper, M.S., D.V.M. 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):
K
Device Name:
extendSURE™ Lyophilized Hemoglobin A1c Linearity Controls
Indications for Use:
For in vitro diagnostic use only. The extendSURE™ lyophilized hemoglobin A1c linearity controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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 C. Benson
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071648
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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.