(85 days)
Not Found
No
The description focuses on a chemical assay and a simple monitor for displaying results, with no mention of AI/ML terms or functionalities.
No
The device is described as a test that provides quantitative measurement of glycated hemoglobin levels, used for monitoring glycemic control in people with diabetes. This indicates a diagnostic or monitoring function, not a therapeutic one.
Yes
This device measures %HbA1c levels to monitor glycemic control in people with diabetes, which is a key indicator used to assess the effectiveness of diabetes management, thus providing information that aids in making clinical decisions.
No
The device description explicitly lists hardware components: a semi-disposable plastic-encased device (the monitor), a plastic cartridge enclosing dry reagent strips, and a sample dilution kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "provides quantitative measurement of the percent of glycated hemoglobin (%HbAIc, %A1C) levels in whole blood samples." This is a measurement performed in vitro (outside the body) on a biological sample (whole blood).
- Device Description: The description details how the device interacts with a "whole blood mixture (diluted)" and uses "dry reagent strips" within a "plastic cartridge." This further confirms that the analysis is being performed on a sample outside the body using reagents.
- Sample Type: The device uses "whole blood samples," which are biological specimens.
- Measurement: It provides a "quantitative measurement" of a specific analyte (%A1C) in the blood.
All of these characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The AlCNow multi-use test provides quantitative measurement of the percent of glycated hemoglobin (%HbAIc, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
The A1CNow+ tests provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used to monitor glycemic control in people with diabetes. A1cNow+ TM consists of 1) a semi-disposable plastic-encased device (the monitor), 2) a plastic cartridge enclosing dry reagent strips, and 3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge. When testing with A1CNow+, an unmeasured whole blood mixture (diluted) is directly applied to the sample port, and the results are displayed in numeric form on the Monitor's liquid crystal display after 5 minutes.
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 and professional 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)
The performance was assessed in two separate clinical validation studies. The studies showed that changes to the hemolysate kit and product stability had no negative impact on product safety and efficacy. In addition, completed and ongoing product stability studies show no negative impacts of increased room temperature shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AlcNow® Multi-Use for Home and Professional Use Special 510(k)- Device Modification for K051321
MAY 14 2009
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
A1CNow® for Home and Professional Use
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is KO904)3
| Prepared: | February 17, 2009 |
|---|---|
| Submitter: | Bayer HealthCare Diabetes Care |
| Address: | 510 Oakmead Parkway |
| Sunnyvale, CA 94085 | |
| Phone (408) 524-2255; FAX (408) 524-2252 | |
| Contact: | Cathy Peters, Manager, Regulatory Affairs |
| Device: | Trade/Proprietary Names: |
| A1CNow+ (Professional Use) | |
| A1CNow Self Check (Home Use) | |
| Common/Usual Name: | Percent Hemoglobin Alc (percent glycosylated hemoglobin) |
| Classification: | Assay, Glycosylated Hemoglobin, 21 CFR 864.7470 |
| Predicate Device: | AlcNow® Multi-Use for Home and Professional Use (InView™) |
| K051321 | |
| Device Description: | The A1CNow+ tests provides quantitative measurement of the |
| percent of glycated hemoglobin (%A1C) levels in capillary | |
| (fingerstick) or venous whole blood samples. The test is used to | |
| monitor glycemic control in people with diabetes. | |
| A1cNow+ TM consists of 1) a semi-disposable plastic-encased device | |
| (the monitor), 2) a plastic cartridge enclosing dry reagent strips, and |
- a sample dilution kit for: collecting the blood sample, mixing the
sample with the required pre-treatment solution, and delivering the
sample to the cartridge. When testing with A1CNow+, an
unmeasured whole blood mixture (diluted) is directly applied to the |
1
sample port, and the results are displayed in numeric form on the Monitor's liquid crystal display after 5 minutes.
Intended Use:
Technological
Characteristics:
percent of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.
The A1CNow multi-use test provides quantitative measurement of the
There were no changes to the intended use or fundamental scientific technology.
Comparison to Predicate device:
A1CNow is the same in fundamental technology and intended use to the predicate device, A1CNow, K051321, but has increased product stability and a simplified hemolysate preparation kit.
Assessment of Performance:
Conclusion:
The performance was assessed in two separate clinical validation studies. The studies showed that changes to the hemolysate kit and product stability had no negative impact on product safety and efficacy. In addition, completed and ongoing product stability studies show no negative impacts of increased room temperature shelf life.
The results of the verification and validation studies of A1CNow demonstrated that the product is safe and effective in the hands of lay users and healthcare professionals. The product is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.
Public Health Service
MAY 14 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bayer HealthCare, LLC c/o Ms. Cathy Peters Regulatory Affairs Manager 510 Oakmead Parkway Sunnyvale, CA 94085
Re: K090413
Trade/Device Name: A1CNow Self Check, A1CNow+ Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: April 14, 2009 Received: April 15, 2009
Dear Ms. Peters:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (sce above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
A.C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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A1cNow® Multi-Use for Home and Professional Use Special 510(k)- Device Modification for K051321
STATEMENT OF INTENDED USE
510(K) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Device Name: A1CNow+ (professional use), A1CNow Self Check (Home Use)
Indications for Use:
The AlCNow multi-use test provides quantitative measurement of the percent of glycated hemoglobin (%HbAIc, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of in Vitro Dlag
510(k) K090413
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