(38 days)
The HemoChek Sample Collection Kit is indicated 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 a filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over an 8-12 week period. The results are to be evaluated by the patient's physician. The product is not indicted for the diagnosis of diabetes mellitus.
The HemoChek Sample Collection Kit is a kit which is sent to the patient's home after the patient has been enrolled in the HemoChek program by the patient's physician. The kit consists of the following:
- A Sample Card containing the proprietary filter paper that the blood sample is deposited on. the patient's name and address, instructions on how to obtain the sample and send it to Osborn Laboratories and a place to make changes to any of the patient's information.
- A pamphlet containing a description of the HemoChek program and detailed instructions about how to obtain a blood sample and mail it to Osborn Laboratories.
- A self-adhesive envelope in which the card is inserted and then mailed to the preprinted address on the envelope.
- The mailing envelope which is used to mail the above three items to the patient.
After receiving the HemoChek Sample Collection Kit in the mail from Osborn Laboratories, the patient then collects a blood sample, using a lancet. The blood sample is placed on all three circles on the right hand side of the sample collection card, as described in the instructions. Then the card is placed in the mailing envelope provided in the kit and mailed to Osborn Laboratories. When the blood sample is received by Osborn Laboratories the patient's HbA1c level is measured using existing assay methods.
The provided text describes the Osborn Laboratories HemoChek Sample Collection Kit, a device intended for collecting blood samples for HbA1c measurement. It outlines the device description, intended use, comparison with a predicate device, and a summary of performance testing.
Here's the breakdown of the acceptance criteria and study information, as much as can be gleaned from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Initial Validation) | "The variation between the whole blood value and the value obtained using a HemoChek Sample Card was within acceptable accuracy limits." |
| Repeatability (Initial Validation) | Validated as part of the accuracy and repeatability study. |
| Accuracy (High HbA1c Specimens) | "The variation between the whole blood value and the value obtained using a HemoChek Sample Card was within acceptable accuracy limits." |
| Environmental Stability (Temperature & Humidity) | "The test results were considered to be within acceptable accuracy limits." |
| Patient Acceptability/Usability | "Overall, the users were very pleased with the product." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions several tests but does not provide specific sample sizes for each:
- Initial Validation (Accuracy & Repeatability): "whole blood specimens were selected to obtain a range of HbA1c levels." Additional "samples were obtained from each specimen using HemoChek Sample Cards."
- High HbA1c Specimens Validation: "blood specimens were taken at a local hospital from a number of persons with high levels of HbA1c."
- Environmental Testing: The number of kits subjected to environmental testing is not specified.
Data Provenance:
- Whole Blood Specimens (Initial Validation): Not explicitly stated, but likely from a laboratory or clinical setting where a range of HbA1c levels could be sampled.
- High HbA1c Specimens: "a local hospital."
The studies appear to be prospective in nature, as they involve collecting and analyzing samples specifically for the validation of the HemoChek Sample Cards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth. The "ground truth" appears to be established by the "existing assay methods" used for analyzing whole blood specimens. These are implied to be standard, validated laboratory methods, but specific details about the personnel performing these assays are not provided.
4. Adjudication Method for the Test Set
No explicit adjudication method is mentioned. The comparison is made between values obtained from whole blood samples (serving as the reference/ground truth) and values obtained from samples collected with the HemoChek Sample Kit, both analyzed using the "same assay method." The "acceptable accuracy limits" imply a pre-defined range of difference that was considered acceptable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a sample collection kit, not an imaging or diagnostic algorithm that would typically involve multiple human readers. The performance evaluation focuses on the accuracy and stability of the collected sample relative to a direct whole blood sample.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of the HemoChek Sample Collection Kit. The device itself is a collection kit and does not involve an algorithm. Its performance is evaluated based on the integrity and accuracy of the collected blood sample, which is then analyzed by existing laboratory assay methods (human-in-the-loop in the lab). There is no "algorithm only" component.
7. The Type of Ground Truth Used
The ground truth used was measurement from existing assay methods on whole blood specimens. This means direct laboratory analysis of unconcentrated blood samples provided the reference values against which the HemoChek collected samples were compared.
8. The Sample Size for the Training Set
No information is provided about a "training set." This type of device (a sample collection kit) typically undergoes validation, not a machine learning training process.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for Osborn Laboratories, which includes a stylized "L" formed by a grid pattern. The text "OSBORN LABORATORIES" is displayed next to the logo, followed by the text "A ChoicePoint Company". Above the logo, the date "JAN 28 1999" is printed.
JAN 28 1999
A ChoicePoint™ Company
510(k) SUMMARY
Osborn Laboratories
HemoChek Sample Collection Kit
December 18, 1998
Submitter Information:
Osborn Laboratories 19401 West 117th Street Olathe, Kansas 66062
Submitter's Name: Phone:
Gilbert P. Bourk III (913) 390-7146
Device Name:
Osborn Laboratories HemoChek Sample Collection Kit
Hemoglobin A1c blood sample collection kit Common Name: Classification Name: Glycosylated Hemoglobin Assay
Predicate Device Equivalence:
Substantial equivalence is claimed to the EZCHEK™/HbA1c Sample Collection Kit, cleared for commercial distribution per K971919.
Device Description:
The HemoChek Sample Collection Kit is a kit which is sent to the patient's home after the patient has been enrolled in the HemoChek program by the patient's physician. The kit consists of the following:
- A Sample Card containing the proprietary filter paper that the blood sample is deposited on. the i patient's name and address, instructions on how to obtain the sample and send it to Osborn Laboratories and a place to make changes to any of the patient's information.
- A pamphlet containing a description of the HemoChek program and detailed instructions about how to l obtain a blood sample and mail it to Osborn Laboratories.
- A self-adhesive envelope in which the card is inserted and then mailed to the preprinted address on the envelope.
- The mailing envelope which is used to mail the above three items to the patient. -
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After receiving the HemoChek Sample Collection Kit in the mail from Osborn Laboratories, the patient then collects a blood sample, using a lancet. The blood sample is placed on all three circles on the right hand side of the sample collection card, as described in the instructions. Then the card is placed in the mailing envelope provided in the kit and mailed to Osborn Laboratories. When the blood sample is received by Osborn Laboratories the patient's HbA1c level is measured using existing assay methods.
Intended Use:
The HemoChek Sample Collection Kit is indicated 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 a filter paper and delivered to the laboratory by mail. The results are to be evaluated by the patient's physician. The product is not indicated for the diagnosis of diabetes mellitus.
Comparison of Technological Characteristics:
Essentially, the two 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 two devices is different. Also, the existing assay methodologies used are different for the two devices.
Summary of Performance Testing:
To validate the accuracy and repeatability of the results obtained using the HemoChek Sample Cards. whole blood specimens were selected to obtain a range of HbA1c levels. Samples of whole blood from each specimen were analyzed using an existing assay method. Next, additional samples were obtained from each specimen using HemoChek Sample Cards and analyzed using the same assay method.
To further validate the HemoChek Sample Cards, blood specimens were taken at a local hospital from a number of persons with high levels of HoA1c. For each specimen, a sample of whole blood and a sample collected using a HemoChek Sample Card were analyzed using the same methodology used in the initial validation discussed in the previous paragraph. The variation between the whole blood value and the value obtained using a HemoChek Sample Card was within acceptable accuracy limits.
To obtain assurance that the blood samples would still provide an accurate assessment of the patients' hemoglobin A 1c levels even after undergoing the extreme temperatures and humidity conditions that can be experienced by any object sent by U.S. Mail, the HemoChek Sample Collection Kit was subiected to environmental testing. The test results were considered to be within acceptable accuracy limits.
To obtain patient comments about the HemoChek Sample Collection Kit. Osborn Laboratories conducted a survey. Overall, the users were very pleased with the product.
Conclusions:
Based on the above, we concluded that the HemoChek Sample Collection Kit is substantially equivalent to a legally marketed predicate device and is safe and effective for its intended use.
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JAN 28 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Gilbert P. Bourk, III Vice President and General Counsel Osborn Laboratory 14901 West 117th Street Olathe, Kansas 66062
Re: K984529
Trade Name: Osborn Laboratories HemoChek Sample Collection Kit Regulatory Class: II Product Code: LCP Dated: December 18, 1998 Received: December 21, 1998
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 (OS) 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 Butman
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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Page / of /
510(k) Number (if known): K984529
Device Name:
HemoChek Sample Collection Kit
Indications for Use:
The HernoChek Sample Collection Kit is indicated 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 a filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over an 8-12 week period. The results are to be evaluated by the patient's physician. The product is not indicted for the diagnosis of diabetes mellitus.
Scan Cooger
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 984529
(PLEASE DO NOT WRITE BELOW THIS LÌNE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
by Prescription
(Optional Format 1-2-96)
§ 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).