(41 days)
The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. The control is intended as a position marker for hemoglobin variant analysis methods such as ion exchange HPLC, capillary electrophoresis, cellulose acetate and agar/agarose gel electrophoresis. The Hemoglobin FASC control will assist in defining the elution time on HPLC or capillary electrophoresis or migration distance on electrophoresis. In this way the common hemoglobin variants can be identified and rare variants that elute close to these can be distinguished for further characterization.
The control is for in vitro diagnostic use only and should not be used past the expiry date.
The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. It contains stabilizers and preservatives to maintain the stability of the hemoglobin variants. The product is provided in a lyophilized form and is reconstituted with 1.0 ml of reconstitution fluid (0.09% sodium azide) prior to use.
The provided text describes a Hemoglobin FASC Variant Control (extendSURE™ HbFASC Control) and its 510(k) submission. However, it does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, or any details related to AI/algorithm performance studies.
Instead, the document focuses on:
- Device Summary: Describing the device, its intended use, and its classification.
- Predicate Device Comparison: Establishing substantial equivalence to previously cleared devices based on analyte composition and intended uses.
- Performance Characteristics (Stability): Reporting results of stability studies that support the shelf life claims.
- FDA Clearance Letter: Confirming the 510(k) clearance and the regulatory classification.
- Indications for Use: Formal statement of the device's intended applications.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies proving the device meets them, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment, as this information is not present in the provided text.
The only "performance characteristic" explicitly mentioned is:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Stability) |
|---|---|
| Not specified | Shelf life (closed vial) at 2° to 8°C of 36 months from manufacture. |
| Not specified | Open vial (reconstituted) stability of 6 weeks at 2° to 8°C. |
For all other points, the information is not available in the provided text.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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: No AI component or MRMC study mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No AI component or standalone algorithm performance mentioned.
7. The type of ground truth used: Not applicable as it's a control material, and "ground truth" for a diagnostic algorithm is not relevant here. The "performance" is about its stability and ability to serve as a marker.
8. The sample size for the training set: Not applicable as it's not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Section 11 510(k) Device Summary
Image /page/0/Picture/2 description: The image contains the logo for Canterbury Scientific. The logo consists of a black circle with a white flask-like design inside, followed by the word "CANTERBURY" in bold, uppercase letters. Below "CANTERBURY" is the website address "www.canterburyscientific.com".
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 كل25303 |
| Submitter | Canterbury Scientific Ltd14 Pope StreetChristchurchNew ZealandPhone +64 3 343 3345FAX +64 3 343 3342 |
|---|---|
| Contact PersonDate of PreparationDevice NameProprietary NameCommon NameClassificationClassProduct Code | Maurice Owen, PhD, Scientific DirectorOctober 4, 2005Hemoglobin FASC Variant ControlextendSURE™ HbFASC ControlHemoglobin FASC Variant Control21CFR 862.1660 Quality Control Material (assayed andunassayed)IIJCM |
| Equivalent Device | Helena Laboratories, AFSC Hemo Control. (510(k) # K933086)Canterbury Health Laboratories, Hemoglobin F & A2 Control(510(k) # K011389) |
| Description of Device | The Hemoglobin FASC Variant Control kit contains HbA, HbF,HbS and HbC. It contains stabilizers and preservatives tomaintain the stability of the hemoglobin variants. The product isprovided in a lyophilized form and is reconstituted with 1.0 mlof reconstitution fluid (0.09% sodium azide) prior to use. |
| Intended Use of Device | The control is intended as a position marker for hemoglobinvariant analysis methods such as ion exchange HPLC, capillaryelectrophoresis, cellulose acetate and agar/agarose gelelectrophoresis. The Hemoglobin FASC control will assist indefining the elution time on HPLC or capillary electrophoresis ormigration distance on electrophoresis. In this way the commonhemoglobin variants can be identified and rare variants that |
{1}------------------------------------------------
elute close to these can be distinguished for further characterization.
The control is for in vitro diagnostic use only and should not be used past the expiry date.
Comparison with Predicate Device
The device (Hemoglobin FASC Variant Control) claims substantial equivalence to device K933086 (AFSC Hemo Control) in terms of analyte composition and intended uses as a qualitative marker of variant hemoglobins to assist in identifying an unknown hemoglobin band or peak.
Substantial equivalence is also claimed to device K011389 (Hemoglobin F & A2 Control) as it is intended to be primarily used on HPLC instruments although suitable for use on electrophoresis systems. Further its form as a lyophilized product and with the same composition of stabilizers and preservatives give enhanced open vial (reconstituted) stability.
Performance Characteristics
Stability studies at 2° to 8°C were performed on the BioRad Variant with the ß-thalassemia short program. The results support a shelf life (closed vial) at 2° to 8°C of 36 months from manufacture and an open vial (reconstituted) claim of 6 weeks at 2° to 8°C.
{2}------------------------------------------------
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 features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Maurice Owen, Ph.D., FACB Scientific Director Canterbury Scientific Limited 14 Pope Street Christchurch 8001 NEW ZEALAND
K053031 Re:
Trade/Device Name: Hemoglobin FASC Variant Control Regulation Number: 21 CFR § 864.7415 Regulation Name: Abnormal Hemoglobin Assay Regulatory Class: II Product Code: JCM Dated: October 25, 2005 Received: October 27, 2005
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.
DEC 7
2005
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). 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.
{3}------------------------------------------------
Page 2 -
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) 276-0484. 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/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PA Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:
Hemoglobin FASC Variant Control
Indications for Use:
The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. The control is intended as a position marker for hemoglobin variant analysis methods such as ion exchange HPLC, capillary and agar/agarose gel cellulose acetate electrophoresis, electrophoresis. The Hemogiobin FASC control will assist in defining the elution time on HPLC or capillary electrophoresis or migration distance on electrophoresis. In this way the common hemoglobin variants can be identified and rare variants that elute close to these can be distinguished for further characterization.
The control is for in vitro diagnostic use only and should not be used past the expiry date.
Prescription Use (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)
Josephine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K053031
Page 1 of 1
§ 864.7415 Abnormal hemoglobin assay.
(a)
Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.(b)
Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.