(105 days)
K861697/A
Not Found
No
The device description and performance studies focus on the physical collection kit and the analytical method used in the laboratory, with no mention of AI or ML.
No
The device is used to collect a blood sample for monitoring blood sugar control, not for treatment.
No
The "Intended Use / Indications for Use" states, "Not indicated for diagnosis of diabetes mellitus." The device is intended for monitoring blood sugar control in individuals already diagnosed with diabetes.
No
The device description clearly outlines a physical kit containing hardware components (lancet, alcohol wipe, filter paper, bags, envelope) for collecting a blood sample. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to obtain a blood sample for laboratory analysis to monitor long-term blood sugar control. This analysis is performed in vitro (outside the body).
- Device Description: The kit contains materials for collecting a biological sample (blood) and sending it to a laboratory for analysis. The analysis itself (determination of hemoglobin A1c %) is an in vitro diagnostic procedure.
- Performance Studies: The performance studies describe the accuracy and precision of measuring blood spots collected with the device, which is directly related to the analytical performance of the in vitro test.
- Predicate Device: The predicate device listed (Self-Assure®/GHb) is also an IVD device used for measuring glycosylated hemoglobin.
While the device itself is a collection kit, its purpose is to facilitate an in vitro diagnostic test performed in a laboratory. Therefore, the device is considered part of the IVD process.
N/A
Intended Use / Indications for Use
The device is intended for at-home or in-office use to collect a sample for hemoglobin A1c determination. The product will be marketed over-the-counter.
For over-the-counter at-home or doctor's office use to obtain a finger stick whole blood sample for laboratory analysis to monitor long-term (4-8 weeks) blood sugar control in uncontrolled diabetes mellitus. This device is not indicated for the diagnosis of diabetes mellitus.
Product codes
LCP
Device Description
The device is a kit containing the materials required to do no no a capillary blood sample from a finger-stick on a piece of filter paper and mail it to a laboratory for determination of its hemoglobin A16 %. The kit contains a lancet, an alcohol wipe, a test request form with filter paper, a biohazard bag, a return envelope with lifter papereturning a result to the patient and/or his/her doctor.
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
at-home or in-office use / Over-The-Counter 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
NONCLINICAL PERFORMANCE DATA: The principal difference as noted in labove is the method of analysis. The new antibody based method, which as cleared uses whole blood or whole blood hemolysate samples, was shown to give accurate results when using blood spots collected on filter paper as judged from the following correlation data: y = 1.03x -0.13; r = 0.988; n = 53. The precision of measuring blood spots was 2.9% within run at 6.7% HbAt. Total precision over a 20 day study was 3.3 % at 6.7% HbAis. The stability of blood spots at temperature extremes was shown to be compatible with expected transport conditions (up to 115°F and to three freeze-thaw cycles).
CLINICAL PERFORMANCE DATA: Kits were evaluated in three sites to confirm the ease of use by medical professionals in an office setting. Results were also correlated to whole blood hemolysate tests as an additional confirmation of the validity of collection on filter paper. Correlation was Y =0.999x + 0.06; r = 0.978; n = 56. Patients given the kit to take home gathered samples and mailed them to the laboratory. These results also correlated very well (y = 0.983x +0.37; r = 0.956; n= 43) to whole blood hemolysate results. Patients filled out questionnaires regarding the ease of use etc. Their comments indicated that the kit is acceptable as designed.
Key Metrics
Correlation (r) from nonclinical data: 0.988
Precision: 2.9% within run, 3.3% total precision
Correlation (r) from clinical data: 0.978 (medical professionals), 0.956 (patients at home)
Predicate Device(s)
K861697/A
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
58 9-5-97
Image /page/0/Picture/2 description: The image shows the text "FLEXSITE DIAGNOSTICS, INC." in a bold, serif font. The word "FLEXSITE" is followed by a stylized globe-like image with horizontal lines. The text is slightly angled upwards from left to right. The overall impression is that of a professional logo or company name.
510(K) SUMMARY
May 21, 1997
| SUBMITTER: | FLEXSITE DIAGNOSTICS, INC.
3543 SW CORPORATE PARKWAY
PALM CITY, FL 34990 |
|-----------------|--------------------------------------------------------------------------------------|
| | PHONE: 561 221-8893
FAX: 561 221-9671 |
| CONTACT PERSON: | Robert Ray
FLEXSITE DIAGNOSTICS, INC.
PHONE: 561 221-8893
FAX: 561 221-9671 |
| TRADE NAME: | EZCHEK™/HbA1c Sample Collection Kit |
| COMMON NAME: | Self-monitoring glycohemoglobin (hemog |
globin Aic Self-monitoring glycohemog. COMMON NAME: capillary blood collection kit.
Glycosylated Hemoglobin Assay CLASSSIFICATION NAME: (21C.F.R. 864.7470)
Self-Assure®/GHb; K861697/A. PREDICATE DEVICE:
The device is a kit containing the materials required to DESCRIPTION: The do no no a capillary blood sample from a finger-stick on a piece of filter paper and mail it to a laboratory for determination of its hemoglobin A16 %. The kit contains a lancet, an alcohol wipe, a test request form with filter paper, a biohazard bag, a return envelope with lifter papereturning a result to the patient and/or his/her doctor.
43 245
1
INTENDED USE: The device is intended for at-home or in-office use to collect a sample for hemoglobin A1c determination. The product will be marketed over-the-counter.
SUMMARY OF TECHNOLOGICAL SIMILARITIES AND DIFFERENCES:
The key components of the kit are functionally identical to SIMILARITIES: those in the Self-Assure kit.
DIFFERENCES: 1. The method of analysis of glycohemoglobin has changed from attinity chromatography to an antibody method from another commercial source. This method is FDA cleared.
-
- The filter paper treatment has been changed to be compatible with the new antibody method. The new treatment is with a standard chemical in common use in clinical labs.
-
- The name of the product has been changed.
NONCLINICAL PERFORMANCE DATA: The principal difference as noted in labove is the method of analysis. The new antibody based method, which as cleared uses whole blood or whole blood hemolysate samples, was shown to give accurate results when using blood spots collected on filter paper as judged from the following correlation data: y = 1.03x -0.13; r = 0.988; n = 53. The precision of measuring blood spots was 2.9% within run at 6.7% HbAt. Total precision over a 20 day study was 3.3 % at 6.7% HbAis. The stability of blood spots at temperature extremes was shown to be compatible with expected transport conditions (up to 115°F and to three freeze-thaw cycles).
CLINICAL PERFORMANCE DATA: Kits were evaluated in three sites to confirm the ease of use by medical professionals in an office setting. Results were also correlated to whole blood hemolysate tests as an additional confirmation of the validity of collection on filter paper. Correlation was Y =0.999x + 0.06; r = 0.978; n = 56. Patients given the kit to take home gathered samples and mailed them to the laboratory. These results also correlated very well (y = 0.983x +0.37; r = 0.956; n= 43) to whole blood hemolysate results. Patients filled out questionnaires regarding the ease of use etc. Their comments indicated that the kit is acceptable as designed.
44
2.46
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 5 1997
Donald R. Stone Flexsite Diagnostics, Tnc. C/O McKenna & Cuneo, L. L. P. 1900 K Street, N.W. -Washington, D.C. 20006-1108
K971919 Re : EZCHEK™/HBA Sample Collection Kit Regulatory Class: II Product Code: LCP August 15, 1997 Dated: Received: August 15, 1997
Dear Mr. Stone:
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 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 The general controls provisions of provisions of the Act. 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (CMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the CMP regulation may result in regulatory action. in addition, FDA may publish further announcements concerning Please note: this your device in the Federal Register. 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 (CHIA-66), Child device may if it does, you should contact categorization: - 16 accessions on 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 described in your 510(k) picmailor of your device to a legally marketed predicate device results in a classification for your marketed predicate device formits your device to proceed to the market.
If you desire specific advice for your device on our labeling II you debire bpcorrart 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Additionally, for questions on Compliance at (301) 594-4588. Compriance ac (30 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 obtained from the brying (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Hutman
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
510(k) Number: K971919
5 IO(P) Number. Its ve
Indications for Use: ..
Indications for Use:
For over-the-counter at home or doctor's office use to obtain a finger stick whole blood sample
s a lot any to tooting to monitor long-term (4-8 weeks) For over-the-counter at bome or doctor's office use to obtain a more success of the second on the second on the second of the second of the security in disable for the For over-the-counter at boze of the ever of 4-8 weeks) blood sugar control in unocellar - con
for laboratory to monitor long-term (4-3 weeks) blood sugar on not indicated for results should of diabetes mellitus.
diagnosis of diabetes mellitus.
(Division ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Division of Chine I Laoura 510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109) OR