(280 days)
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No
The provided text does not contain any mention of AI, ML, deep learning, neural networks, or any related terms or concepts. The description focuses on the intended use and indications for a device measuring A1c.
No.
The device is used for diagnostic purposes (determining A1c percentage) and measures a patient's condition, rather than treating or curing it.
Yes
Explanation: The device is used for the determination of percent of hemoglobin A1c, which is a clinical measurement used to assess long-term glycemic control in diabetic patients, indicating a diagnostic function.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The intended use describes a determination of hemoglobin A1c in blood samples, which typically requires a physical measurement device. Without a description of how this determination is made, it's impossible to confirm if it's purely software-based analysis of data from another source or if the device itself includes hardware for sample analysis.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the determination of percent of hemoglobin A1c in human whole blood samples." This involves testing a biological sample (whole blood) outside of the body to obtain diagnostic information.
- Clinical Use: It's intended to be used as a measure of long-term glycemic control in patients with diabetes mellitus, which is a clinical application for diagnostic purposes.
- Sample Type: It uses "human whole blood samples," which is a common sample type for in vitro diagnostic tests.
The definition of an IVD generally involves tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health, including diagnosis, monitoring, or screening. The A1c-EXPRESS fits this description perfectly.
N/A
Intended Use / Indications for Use
The intended use of Express-Med's A1c-EXPRESS is for the determination of percent of hemoglobin A1c in human whole blood samples. Clinically, Express-Med's A1c-EXPRESS is intended to be used as a measure of longterm glycemic control in patients with diabetes mellitus. This product will be available to patients through Point of Care offices.
Preferably, A1c-EXPRESS should be used in conjunction with other diabetes management tools, including consultation with health care professionals, goal-setting, education, exercise, diet, and, when prescribed, medication.
A1c-EXPRESS does not replace daily blood glucose monitoring.
Product codes
LCP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Point of Care offices
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 5 1998
D. Alan Scantland Commercial Development Express-Med, Inc. 3592 Coporate Drive Columbus, Ohio 43231-4978
K973365 Re : A.c - Express II Requlatory Class: Product Code: LCP Dated: April 8, 1998 Received: April 9, 1998
Dear Mr. Scantland:
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 provisions The general controls provisions of the Act 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 Requlations, 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 In addition, FDA may publish further announcements action. 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 requlations.
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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 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/dsmamain.html".
Sincerely yours,
Steven Litman
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
2
INDICATIONS FOR USE STATEMENT
The Office of Device Evaluation (ODE) has developed the attached optional form to assist them with instituting the requirement for all original 510(k)s received by ODE on or after 1/2/96.
The requirement is for all 510(k) submissions to have clearly defined "Indications for Use". These indications will be attached by ODE to any substantial equivalence (SE) letter to define what the device is cleared for.
No 510(k) submitted on or after 1/2/96 will be cleared for marketing by ODE without the inclusion of the indications for use information, which will be attached to an SE letter.
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K973365 |
|---|---|
| Device Name: | A₁c-EXPRESS: Hemoglobin A₁c Sample Collection Kit |
Indications For Use:
We propose the following Indications for Use Statement.
The intended use of Express-Med's A16-EXPRESS is for the determination of percent of hemoglobin Aic in human whole blood samples. Clinically, Express-Med's Ate-EXPRESS is intended to be used as a measure of longterm glycemic control in patients with diabetes mellitus. This product will be available to patients through Point of Care offices.
Preferably, Aic-EXPRESS should be used in conjunction with other diabetes management tools, including consultation with health care professionals, goal-setting, education, exercise, diet, and, when prescribed, medication.
A, -EXPRESS does not replace daily blood glucose monitoring.
There are no known contraindications.
The kit should be kept out of reach of children.
(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 | K973365 |
OR
| Description Use
| (Per 21 CFR 801.109) | |
|---|---|
| Over-The-Counter Use |
(Optional Format 1-2-)2-96)