(278 days)
The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus.
The HemoChek-A1c Sample Collection Kit is a kit which is purchased by a patient a pharmacy or other retail store. The kit consists of the following:
- A Sample Card containing the proprietary filter paper that the blood sample is placed on and a place for the patient to print his/her name, address, social security number and the sample was collected
- A pamphlet containing detailed instructions about how to obtain a blood sample and mail it to Osborn -Group, Inc.
- A specimen envelope with the words "After blood has dried, insert completed HemoChek test in this envelope. Seal flap and place in envelope" printed on it
- A self-adhesive envelope in which the card is inserted and then mailed to Osborn Group, Inc. -
- A sterile lancet -
- An alcohol swab -
- A gauze pad -
- An adhesive bandage -
- -An outer package containing all of the items listed above
After purchasing the HemoChek-A1c Sample Collection Kit, the patient then prints the required information on the Sample Card and collects a blood sample, using a lancet (either the one provided in the kit, one provided by the patient's physician or one supplied by the patient). The blood sample is placed on both circles on the right hand side of the Sample Card, as described in the instructions. The Sample Card is then placed in the specimen envelope which in turn is placed in the mailing envelope provided in the kit and mailed to Osborn Group, Inc. When the blood sample is received by Osborn Group, Inc., the patient's HbA1c level is measured using existing assay methods. The results are then mailed to the patient.
The provided text is a 510(k) summary for the HemoChek-A1c Sample Collection Kit. This document focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria and proving performance against them through a detailed study.
Therefore, many of the requested information points (1-9) about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in this type of regulatory submission.
Here's an analysis based on the available text:
Acceptance Criteria and Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it asserts "substantial equivalence" to predicate devices. The core "acceptance criteria" in this regulatory context is the demonstration that the new device is as safe and effective as a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | The HemoChek-Atc performs in the same manner as the HemoChek predicate device. |
| Intended Use Equivalence | "The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus." (Identical to predicate's intended use implied) |
| Technological Characteristics Equivalence | "Essentially, the devices use the same basic technology, i.e., collecting a blood sample and analyzing it using an existing assay methodology." (Acknowledges physical size difference and different assay methodologies than one predicate but same as another predicate, implying overall equivalence). |
| Performance Characteristics Equivalence | "Information contained in this submission demonstrates that the HemoChek-Atc performs in the same manner as the HemoChek predicate device." (Specific performance data not provided in this summary). |
2. Sample Size Used for the Test Set and Data Provenance:
- Not explicitly stated. The summary mentions "Information contained in this submission demonstrates..." but does not detail the size of any test set or the provenance of the data (e.g., country of origin, retrospective or prospective). Regulatory submissions for substantial equivalence often rely on various types of data, but the specifics are not in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not stated. Ground truth establishment by experts in the context of diagnostic accuracy is not discussed here, as the focus is on substantial equivalence of a sample collection kit. The "ground truth" would likely relate to the accuracy of the HbA1c assay itself, which is a separate established methodology.
4. Adjudication Method for the Test Set:
- Not applicable/Not stated. Since a specific "test set" and a diagnostic accuracy study with multiple readers are not described, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is not mentioned as the device is a sample collection kit, not an AI or imaging diagnostic device where MRMC studies are common.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The HemoChek-A1c is a physical sample collection kit, not an algorithm, so a "standalone" performance study in the context of AI is not relevant. The performance evaluation would focus on its ability to collect and preserve samples for subsequent laboratory analysis.
7. The Type of Ground Truth Used:
- Not explicitly stated in relation to device performance. For a sample collection kit, "ground truth" would likely involve the accurate measurement of HbA1c in the lab using established, validated assay methods on samples collected with the kit compared to other methods (e.g., venous blood draw). The summary only states that "the patient's HbA1c level is measured using existing assay methods."
8. The Sample Size for the Training Set:
- Not applicable/Not stated. This refers to machine learning models, which is not the nature of this device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not stated. As above, this pertains to machine learning and not a physical sample collection kit.
Summary of available information:
The document is a 510(k) summary demonstrating substantial equivalence for a medical device (HemoChek-A1c Sample Collection Kit) to existing predicate devices (EZCHEK™/HbA1c Sample Collection Kit and HemoChek Sample Collection Kit). The primary "study" referred to is the submission of information that "demonstrates that the HemoChek-Atc performs in the same manner as the HemoChek predicate device." No specific detailed study, sample sizes, or performance metrics within that study are provided in this summary, as the regulatory path relies on demonstrating similarity to already cleared devices.
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1990899
DEC 2 1 1999
Image /page/0/Picture/2 description: The image shows the logo for Osborn Group, INC. The logo is in black and white and features a curved line above the word "OSBORN". Below the company name is the text "A ChoicePoint Company" in a smaller font. The logo is simple and professional.
510(k) SUMMARY
Osborn Group, Inc.
HemoChek-A1c Sample Collection Kit
March 17, 1999
Submitter Information:
Osborn Group, Inc. 19401 West 117th Street Olathe, Kansas 66062
Submitter's Name: Phone:
Gilbert P. Bourk III (913) 390-7146
Device Name:
HemoChek-A1c Sample Collection Kit
Common Name: Hemoglobin A1c blood sample collection kit
Classification Name: Glycosvlated Hemoglobin Assay
Predicate Device Equivalence:
Substantial equivalence is claimed to the EZCHEK™/HbA1c Sample Collection Kit, and to the HemoChek Sample Collection Kit, cleared for commercial distribution per K971919 and K984529, respectively.
Device Description:
The HemoChek-A1c Sample Collection Kit is a kit which is purchased by a patient a pharmacy or other retail store. The kit consists of the following:
- A Sample Card containing the proprietary filter paper that the blood sample is placed on and a place for the patient to print his/her name, address, social security number and the sample was collected
- A pamphlet containing detailed instructions about how to obtain a blood sample and mail it to Osborn -Group, Inc.
- A specimen envelope with the words "After blood has dried, insert completed HemoChek test in this envelope. Seal flap and place in envelope" printed on it
- A self-adhesive envelope in which the card is inserted and then mailed to Osborn Group, Inc. -
Image /page/0/Picture/23 description: The image shows the logo for Osborn Laboratories, a ChoicePoint company. The logo features a stylized letter "L" formed by a grid pattern within a circle. To the right of the circular element, the words "OSBORN LABORATORIES" are printed in a simple, sans-serif font, with the tagline "A ChoicePoint Company" appearing in a smaller font size below.
Image /page/0/Picture/24 description: The image shows the logo for Intellisys, an Osborn Company. The word "INTELLISYS" is written in a bold, sans-serif font, with a curved line above it. Below the word "INTELLISYS" is the phrase "AN OSBORN COMPANY" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.
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- A sterile lancet -
- An alcohol swab -
- A gauze pad -
- An adhesive bandage -
- -An outer package containing all of the items listed above
After purchasing the HemoChek-A1c Sample Collection Kit, the patient then prints the required information on the Sample Card and collects a blood sample, using a lancet (either the one provided in the kit, one provided by the patient's physician or one supplied by the patient). The blood sample is placed on both circles on the right hand side of the Sample Card, as described in the instructions. The Sample Card is then placed in the specimen envelope which in turn is placed in the mailing envelope provided in the kit and mailed to Osborn Group, Inc. When the blood sample is received by Osborn Group, Inc., the patient's HbA1c level is measured using existing assay methods. The results are then mailed to the patient.
Intended Use:
The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus.
Comparison of Technological Characteristics:
Essentially, the devices use the same basic technology, i.e., collecting a blood sample and analyzing it using an existing assay methodology. However, the physical size of the device is different than the EZCHEK predicate device. Also, the existing assay methodologies used are different for the device and the EZCHEK predicate device, but are the same as for the HemoChek predicate device.
Summary of Performance Testing:
Information contained in this submission demonstrates that the HemoChek-Atc performs in the same manner as the HemoChek predicate device.
Conclusions:
Based on the above, we concluded that the HemoChek-A1c Sample Collection Kit is substantially equivalent to legally marketed predicate devices and iffective for its intended use.
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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 21 1999
Mr. Gilbert P. Bourk III Vice President and General Counsel Osborn Group, Inc. 14901 West 117th Street Olathe, Kansas 66062
K990899 Re:
Trade Name: HemoChek-A1c™ Sample Collection Kit Regulatory Class: II Product Code: LCP Dated: October 29, 1999 Received: November 1, 1999
Dear Mr. Bourk:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Osborn Group, Inc. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name is the text "A ChoicePoint Company" in a smaller font. A curved line extends from the top of the "O" in Osborn to the bottom of the "N".
Device Name:
HemoChek-A1c™ Sample Collection Kit
Indications for Use:
The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus.
Peter E. Makris
(Division Sign-Off)
Division of Clinical Laboratory Devices Ka90899
510(k) Number
ver the counter.
Image /page/4/Picture/11 description: The image shows the logo for Osborn Laboratories. The logo consists of a circular design on the left, made up of small squares, with a larger square in the center. To the right of the circular design, the text "OSBORN LABORATORIES" is displayed in a simple, sans-serif font. Below this, the text "A ChoicePoint Company" is written in a smaller font size.
Image /page/4/Picture/9 description: The image shows the logo for Intellisys, an Osborn Company. The word "INTELLISYS" is in large, bold, sans-serif font, with a line underneath. Below the line, in a smaller font, it says "AN OSBORN COMPANY". There is a curved line above and to the right of the word "INTELLISYS".
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).