(178 days)
Not Found
No
The device description and performance studies focus on the collection and laboratory analysis of blood samples, with no mention of AI or ML being used in the process or interpretation of results.
No
This device is an in vitro diagnostic (IVD) device used for monitoring, not for treating or preventing disease. It provides information about a patient's hemoglobin A1c levels, which can assist in managing diabetes, but it does not perform a therapeutic function itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "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 term "in vitro diagnostic" confirms its use for diagnostic purposes, even though it's specifically for monitoring and not initial diagnosis of diabetes.
No
The device description clearly outlines a physical kit containing various hardware components (filter paper card, lancets, bandages, etc.) for collecting a blood sample. It does not describe a software-only product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro diagnostic quantitative office ass arrive for oglobin Alc (glycosylated hemoglobin)" and "monitoring long-term glucose control in people with diabetes." This clearly indicates the device is used to perform a diagnostic test on a biological sample (blood) outside of the body.
- Device Description: The device is a kit designed to collect a blood sample for laboratory analysis. This is a common characteristic of IVD devices.
- Performance Studies: The performance studies focus on evaluating the accuracy and reliability of the test results obtained from the collected blood samples, which is essential for demonstrating the performance of an IVD.
- Predicate Device: The predicate device listed (K971919; EZCHEK/HBA Blood Collection Kit by Flexsite Diagnostics) is also an IVD, further supporting the classification of this device as an IVD.
The fact that it's intended for home-use or office-use and marketed over-the-counter doesn't change its classification as an IVD. It simply indicates the intended user and distribution channel.
N/A
Intended Use / Indications for Use
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.
Product codes
LCP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home-use or office-use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance studies were conducted on blood samples collected by both a trained health care professional and the lay user at three different geographical sites. 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 for Monitoring Hemoglobin Alc. Patients were instructed to self-collect their own capillary blood samples within 24 hours after leaving the collection site. All samples collected were mailed directly back to BioSafe Laboratories for determination of percent hemoglobin Alc.
Performance characteristics studied included precision and correlation. In addition, the Safe at Home Test Kit for Monitoring Hemoglobin Alc was evaluated for reagent and sample stability when exposed to abusive conditions. Study participants were requested to complete and return questionnaires regarding the kit's ease of use.
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.
Study subjects indicated that the kit is acceptable as designed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
G - I
510(k) Summary
| 1) Submitter's Name
Address, contact | BioSafe Diagnostic Corporation
300 Knightsbridge Parkway, Suite 320
Lincolnshire, IL
Phone: (847) 821-7300
FAX: (847) 821-7400
Contact Person: Steven Tyrrell
BioSafe Laboratories
(773) 693-0400, x222
Date Prepared: May 28, 1999 | | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--|
| 2) Device Name | Proprietary Name: | Safe At Home Test Kit for
Monitoring Hemoglobin A1c | |
| | Common Name: | Self-monitoring Glycohemoglobin
Blood Collection Kit | |
| | Classification Name: | Glycosylated Hemoglobin Assay
(21 CFR 864.7470) | |
| 3) Predicate Device | EZCHEK/HBA Blood Collection Kit by Flexsite
Diagnostics (#K971919), currently marketed by Becton
Dickinson as the BD A1c At Home TestTM | | |
| 4) Device
Description | 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. | | |
| 5) Intended Use | 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. | | |
Continued on next page
e;
1
510(k) Summary, continued
| 6) Comparison to
predicate device | The Safe At Home Test Kit for Monitoring Hemoglobin
Alc has essentially the same intended use, technological
characteristics and components as the predicate device.
The components are the same except that the Flexsite
Diagnostic'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 kits
differ also in that the blood collection spot paper in the
Flexsite device is attached to the Test Request Form
whereas these two components are separate in the BioSafe
device. The use of this kit affects only the sample
collection stage of the testing procedure. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7) Performance Studies | Performance studies were conducted on blood samples
collected by both a trained health care professional and the
lay user at three different geographical sites. 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 for Monitoring
Hemoglobin Alc. Patients were instructed to self-collect
their own capillary blood samples within 24 hours after
leaving the collection site. All samples collected were
mailed directly back to BioSafe Laboratories for
determination of percent hemoglobin Alc.
Performance characteristics studied included precision and
correlation. In addition, the Safe at Home Test Kit for
Monitoring Hemoglobin Alc was evaluated for reagent
and sample stability when exposed to abusive conditions.
Study participants were requested to complete and return
questionnaires regarding the kit's ease of use. |
| 9) Test Summary | 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.
Study subjects indicated that the kit is acceptable as
designed. |
2
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.
3
Page 2
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
4
Page__of_
| 510(k) Number (if known): | K99185D |
|---|---|
| --------------------------- | --------- |
Device Name: _________________________________________________________________________________________________________________________________________________________________
C - I
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)