(178 days)
The Safe At Home Test Kit for Monitoring Hemoglobin A1c is intended for home-use or office-use for collection and qualitative determination of hemoglobin A1c in dried whole blood. The product will be marketed over-the-counter.
The Safe at-Home Test Kit for Hemoglobin A1c is intended as a home-use or office-use device for collection of capillary blood for in vitro diagnostic quantitative office ass arrive for oglobin Alc (glycosylated hemoglobin). The device will be used for monitoring long-term glucose control in people with diabetes. This kit is not indicated for the diagnosis of diabetes mellitus.
The device is a kit containing the materials necessary to collect a whole blood sample on a filter paper card and return the card by mail to the laboratory for determination of hemoglobin A1c. The kit comprises of a filter paper card in a resealable shipping bag containing a desiccant pouch, alcohol prep pad, disposable lancets, bandage strip instruction booklet, a return envelope, and a patient test authorization form.
The provided document, K991850, describes the "Safe At Home Test Kit for Monitoring Hemoglobin A1c." Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific numerical acceptance criteria (e.g., minimum correlation coefficient, specific precision ranges). Instead, it broadly states that the studies were designed to evaluate "precision and correlation" and that the "evaluation studies provided evidence that results obtained using blood samples from untrained lay users correlate well with whole blood samples and capillary blood samples collected by trained health care professionals."
A more direct "reported device performance" is also not provided in quantitative detail. The document concludes with a qualitative statement: "Study subjects indicated that the kit is acceptable as designed."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Performance studies were conducted on blood samples collected by both a trained health care professional and the lay user at three different geographical sites." It does not specify the number of samples or participants.
- Data Provenance: The studies were conducted at "three different geographical sites," suggesting a prospective collection of data. The country of origin is not explicitly stated, but given the FDA submission, it's highly likely to be the USA. Data was collected from "lay user" and "a trained health care professional," with venous blood samples collected by the healthcare professional and capillary samples self-collected by patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The document refers to "a trained health care professional" who collected corresponding venous blood samples. Their specific qualifications (e.g., physician, nurse, phlebotomist) are not detailed.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. It describes a comparison between samples collected by lay users/healthcare professionals and corresponding venous blood samples.
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, an MRMC comparative effectiveness study was not done. This device is a blood collection kit, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical kit for blood collection and is not an algorithm that operates in a standalone manner. The "performance" refers to the integrity of the collected sample and its correlation with laboratory results.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth appears to be based on laboratory-determined percent hemoglobin A1c from venous blood samples collected by a trained healthcare professional. The document states:
"A corresponding venous blood sample was collected by the health care professional in order to compare whole blood sample results to those obtained from dried blood samples collected on the Safe At Home Kit."
8. The Sample Size for the Training Set
This information is not provided in the document. The concept of a "training set" typically applies to machine learning algorithms, which is not the primary focus of the performance study for this blood collection kit.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as there is no mention of a training set in the context of an algorithm.
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510(k) Summary
| 1) Submitter's NameAddress, contact | BioSafe Diagnostic Corporation300 Knightsbridge Parkway, Suite 320Lincolnshire, ILPhone: (847) 821-7300FAX: (847) 821-7400Contact Person: Steven TyrrellBioSafe Laboratories(773) 693-0400, x222Date Prepared: May 28, 1999 | ||
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| 2) Device Name | Proprietary Name: | Safe At Home Test Kit forMonitoring Hemoglobin A1c | |
| Common Name: | Self-monitoring GlycohemoglobinBlood Collection Kit | ||
| Classification Name: | Glycosylated Hemoglobin Assay(21 CFR 864.7470) | ||
| 3) Predicate Device | EZCHEK/HBA Blood Collection Kit by FlexsiteDiagnostics (#K971919), currently marketed by BectonDickinson as the BD A1c At Home TestTM | ||
| 4) DeviceDescription | The device is a kit containing the materials necessary tocollect a whole blood sample on a filter paper card andreturn the card by mail to the laboratory for determinationof hemoglobin A1c. The kit comprises of a filter papercard in a resealable shipping bag containing a desiccantpouch, alcohol prep pad, disposable lancets, bandage stripinstruction booklet, a return envelope, and a patient testauthorization form. | ||
| 5) Intended Use | The Safe At Home Test Kit for Monitoring HemoglobinA1c is intended for home-use or office-use for collectionand qualitative determination of hemoglobin A1c in driedwhole blood. The product will be marketed over-the-counter. |
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510(k) Summary, continued
| 6) Comparison topredicate device | The Safe At Home Test Kit for Monitoring HemoglobinAlc has essentially the same intended use, technologicalcharacteristics and components as the predicate device.The components are the same except that the FlexsiteDiagnostic's predicate device (BD Alc At Home Test TM)does not include an alcohol preparation pad for pre-cleaning the patient's finger or a bandage strip. The kitsdiffer also in that the blood collection spot paper in theFlexsite device is attached to the Test Request Formwhereas these two components are separate in the BioSafedevice. The use of this kit affects only the samplecollection stage of the testing procedure. |
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| 7) Performance Studies | Performance studies were conducted on blood samplescollected by both a trained health care professional and thelay user at three different geographical sites. Acorresponding venous blood sample was collected by thehealth care professional in order to compare whole bloodsample results to those obtained from dried blood samplescollected on the Safe At Home Kit for MonitoringHemoglobin Alc. Patients were instructed to self-collecttheir own capillary blood samples within 24 hours afterleaving the collection site. All samples collected weremailed directly back to BioSafe Laboratories fordetermination of percent hemoglobin Alc.Performance characteristics studied included precision andcorrelation. In addition, the Safe at Home Test Kit forMonitoring Hemoglobin Alc was evaluated for reagentand sample stability when exposed to abusive conditions.Study participants were requested to complete and returnquestionnaires regarding the kit's ease of use. |
| 9) Test Summary | The evaluation studies provided evidence that resultsobtained using blood samples from untrained lay userscorrelate well with whole blood samples and capillaryblood samples collected by trained health careprofessionals.Study subjects indicated that the kit is acceptable asdesigned. |
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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 26 1999
Mr. Steven P. Tyrrell Vice President, Director Research and Development BioSafe Diagnostics Corporation 300 Knightsbridge Parkway Suite 320 Lincolnshire, Illinois 60069
K991850 Re:
Trade Name: Safe At Home Test Kit for Monitoring Hemoglobin Alc Regulatory Class: II Product Code: LCP Dated: September 2, 1999 Received: September 7, 1999
Dear Mr. Tyrrell:
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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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| 510(k) Number (if known): | K99185D |
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Device Name: _________________________________________________________________________________________________________________________________________________________________
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C. Indications for Use Statement
The Safe at-Home Test Kit for Hemoglobin A1c is intended as a home-use or office-use device for collection of capillary blood for in vitro diagnostic quantitative office ass arrive for oglobin Alc (glycosylated hemoglobin). The device will be used for monitoring long-term glucose control in people with diabetes. This kit is not indicated for the diagnosis of diabetes mellitus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K991850 |
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | --- |
OR
Over-The-Counter Use (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).