(85 days)
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.
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+ 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.
The provided text describes a 510(k) submission for a device modification (AlcNow® Multi-Use) and does not contain detailed acceptance criteria and performance data in a tabular format typically found in clinical study reports. It broadly states that the device is "safe and effective" and "substantially equivalent" to its predicate.
Based on the provided document, here's what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific numerical acceptance criteria or detailed performance metrics. It generally states that "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."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set(s) or the data provenance (e.g., country of origin, retrospective/prospective nature). It only mentions "two separate clinical validation studies."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information on the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication methods used for the test set.
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
This device (A1CNow®) is a diagnostic assay for measuring glycated hemoglobin, not an AI-assisted imaging device or one involving "human readers" in the context of MRMC studies typical for image-based diagnostic aids. Therefore, an MRMC comparative effectiveness study, as described, is not applicable or mentioned for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The A1CNow® device is an automated in vitro diagnostic device. Its performance is inherently "standalone" in that it directly measures %A1C from a blood sample. The "studies showed that changes to the hemolysate kit and product stability had no negative impact on product safety and efficacy" implies standalone performance evaluation of the device's accuracy and reliability. However, the document does not explicitly use the term "standalone performance study" in the context of algorithm-only performance. It notes that the product is "safe and effective in the hands of lay users and healthcare professionals," suggesting evaluation of its overall use, not just the technical core.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an A1C measurement device, the "ground truth" would typically be established by a reference method for A1C measurement (e.g., HPLC methods that are traceable to the DCCT reference method) in a clinical laboratory. The document does not explicitly state how the ground truth was established, but this is the standard approach for such assays.
8. The sample size for the training set
The document does not mention the concept of a "training set" as it would apply to machine learning algorithms. This device is a biochemical assay, not an AI/ML-based diagnostic. Therefore, information on a "training set" is not relevant or provided.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI/ML model, this information is not applicable or provided.
Summary of what is available vs. missing:
The provided text serves as a 510(k) summary for a device modification, focusing on establishing substantial equivalence. It describes the device, its intended use, and states that performance was assessed through clinical validation studies, concluding "no negative impact on product safety and efficacy" and "substantially equivalent." However, it lacks the detailed quantitative performance metrics, sample sizes, ground truth methodologies, and specific study designs that would typically constitute a comprehensive report of acceptance criteria and proven performance for a clinical study.
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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 ParkwaySunnyvale, CA 94085Phone (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 thepercent of glycated hemoglobin (%A1C) levels in capillary(fingerstick) or venous whole blood samples. The test is used tomonitor 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, and3) a sample dilution kit for: collecting the blood sample, mixing thesample with the required pre-treatment solution, and delivering thesample to the cartridge. When testing with A1CNow+, anunmeasured whole blood mixture (diluted) is directly applied to the |
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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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Page - 2
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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§ 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).