(361 days)
The skyla Hi Hemoglobin A1c System, consisting of the skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA Ic %) in venous and finger-stick capillary whole blood.
The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus.
This system is intended for clinical laboratory and point-of-care use.
This test is not for screening or diagnosis of diabetes.
The skyla Hi Analyzer is a portable and compact system, and was designed with skyla Hi Hemoglobin A1c Reagent Kit for on-site quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in human blood.
The provided document describes the FDA 510(k) clearance for the Skyla Hi Hemoglobin A1c System. This is an in-vitro diagnostic device that measures glycated hemoglobin (HbA1c %) in blood for monitoring long-term glycemic control in persons previously diagnosed with diabetes mellitus.
Therefore, the acceptance criteria and study detailed below relate to the analytical and clinical performance of this diagnostic device, not an AI/ML-based device. The concepts of "experts establish ground truth," "adjudication," "multi-reader multi-case," and "standalone algorithm performance" are not directly applicable in the context of an in-vitro diagnostic device clearance, as these are typically used for imaging or AI/ML-driven diagnostic aids.
However, I can extract and present the performance data and study design details relevant to this type of device based on the provided text.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for an in-vitro diagnostic device typically involve precision (reproducibility and repeatability) and method comparison (accuracy against a reference method). The reported device performance is demonstrated through studies detailed in the "Discussion of Non-Clinical Tests Performed" and "Discussion of Clinical Tests Performed" sections.
Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Performance Metric | Implied Acceptance Criteria (Typically based on industry standards, clinical relevance, or predicate device performance. Not explicitly stated as "acceptance criteria" but demonstrated through study results.) | Reported Device Performance (Skyla Hi Hemoglobin A1c System) |
|---|---|---|
| Precision | Demonstrated acceptable levels of repeatability (within-run), between-run, between-day, and total precision. (Typically defined by %CV or SD targets at different HbA1c levels, often derived from clinical guidelines or predicate device performance). | Total Precision (Combined Sites): - Patient 1 (Mean 5.04%): 0.095 SD (1.9% CV) - Patient 2 (Mean 5.56%): 0.110 SD (2.0% CV) - Patient 3 (Mean 6.54%): 0.135 SD (2.1% CV) - Patient 4 (Mean 7.96%): 0.198 SD (2.5% CV) - Patient 5 (Mean 12.10%): 0.292 SD (2.4% CV) - Control 1 (Mean 5.20%): 0.130 SD (2.5% CV) - Control 2 (Mean 9.69%): 0.260 SD (2.7% CV) - Calibrator 1 (Mean 13.58%): 0.138 SD (1.0% CV) |
| Linearity | Demonstrated linearity across the claimed measuring range. | Evaluated (mentioned as "Evaluations included linearity"), but specific results/range are not provided in the summary. |
| Method Comparison (Accuracy/Correlation) | Demonstrated strong correlation and agreement with a legally marketed comparator device or a recognized reference method. (Typically assessed via regression analysis, bias analysis, or Bland-Altman plots with acceptable limits). | Against Bio-Rad VARIANT II Hemoglobin testing system: - Venous Whole Blood: y = 0.9945x + 0.0779 - Finger-stick Capillary Blood: y = 0.9993x + 0.0589 (Conclusion: "comparable to comparative device whole blood testing results.") |
| Interference | Demonstrated that common interfering substances do not significantly impact results. | Evaluated (mentioned as "Evaluations included interference"), but specific results/substances are not provided in the summary. |
| Sample Volume | Demonstrated consistent performance across acceptable sample volume ranges. | Evaluated (mentioned as "Evaluations included sample volume"), but specific results/ranges are not provided in the summary. |
| Hematocrit | Demonstrated consistent performance across a range of hematocrit levels. | Evaluated (mentioned as "Evaluations included hematocrit"), but specific results/ranges are not provided in the summary. |
Study Details:
-
Sample sizes used for the test set and the data provenance:
-
Precision Test Set:
- Total samples: 8 different samples (5 patient samples, 2 control samples, 1 calibrator).
- Total runs/measurements: For each sample, 80 measurements were performed at each of the 3 sites, totaling 240 measurements per sample type. This is broken down into within-run, between-run, and between-day components.
- Provenance: Not explicitly stated, but typically these are controlled laboratory studies using patient samples, control materials, and calibrators. The presence of "Site 1, Site 2, Site 3" indicates a multi-site study. It is likely prospective collection for study purposes. Country of origin for data is not specified.
-
Method Comparison Test Set (POC User Performance Study):
- Total samples: A total of 243 samples were analyzed.
- Provenance: The study was performed in "POC sites by intended operators," suggesting a prospective clinical study environment. The samples included both venous whole blood and finger-stick capillary samples. Country of origin for data is not specified.
-
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of an in-vitro diagnostic device like an HbA1c assay. The "ground truth" for HbA1c measurements is established by a reference method, not by expert consensus or interpretations. In this case, the Bio-Rad VARIANT II Hemoglobin testing system served as the comparator/reference method for the method comparison study.
-
Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation of complex data (e.g., medical images) where there can be inter-reader variability. For an HbA1c assay, the output is a quantitative numerical value, and the comparison is direct to a reference method result.
-
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:
- Not applicable. This is not an AI/ML-assisted diagnostic device, and there are no "human readers" interpreting images or similar data. The study is evaluating the analytical and clinical performance of a laboratory/point-of-care instrument.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. While the device (Skyla Hi Hemoglobin A1c System) operates independently to produce a numerical result, the concept of "standalone algorithm performance" typically applies to AI/ML systems generating an output that would then be presented to a human for review/decision. Here, the device is the analytical system. Its performance is demonstrated directly by the precision and method comparison studies.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the method comparison study was the results obtained from a legally marketed predicate device/reference method, specifically the Bio-Rad VARIANT II Hemoglobin testing system. The performance is assessed by correlating the results of the new device with this established method. For precision studies, there isn't a "ground truth" in the same sense; rather, the "true value" is approximated by the mean of many measurements, and variability around that mean is assessed.
-
The sample size for the training set:
- This refers to the development of the device itself (e.g., calibration, reagent formulation, software algorithms). The document does not specify a "training set" size in the way it would for an AI/ML model. The device's internal algorithms and calibration are developed through internal R&D processes and validated with various studies (e.g., linearity, calibrator assignments), which are generally proprietary and not detailed in a 510(k) summary beyond their successful completion.
-
How the ground truth for the training set was established:
- Not explicitly mentioned in the context of "training data" for an AI/ML model. For an in-vitro diagnostic device, the "training" (development and calibration) would involve using reference materials, calibrators traceable to international standards (if applicable for HbA1c, e.g., IFCC), and characterized patient samples, with their values established by highly accurate methods or external reference laboratories.
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September 25, 2018
Skyla Corporation H.S.P.B. % Feng-Yu Lee, Regulatory Principal Consultant IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675
Re: K173127
Trade/Device Name: skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin Alc Reagent Kit) Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JJE Dated: August 10, 2018 Received: August 22, 2018
Dear Feng-Yu Lee:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173127
Device Name
The skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit)
Indications for Use (Describe)
The skyla Hi Hemoglobin A1c System, consisting of the skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA Ic %) in venous and finger-stick capillary whole blood.
The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus.
This system is intended for clinical laboratory and point-of-care use.
This test is not for screening or diagnosis of diabetes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
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 K173127.
APPLICANT INFORMATION: I.
Name: Skyla Corporation Hsinchu Science Park Branch
Address: 1F, No. 8, Dusing Road, Hsinchu Science Park, Hsinchu 300, Taiwan, R.O.C. +886-3-5787722 Phone: Fax: +886-3-5795393 Contact: Ian Lee
c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928
Date Summary Prepared: September 24th, 2018
II. DEVICES INFORMATION:
Trade Name:
The skyla Hi Hemoglobin Alc System (skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit)
Classification name, product code, and regulation number:
| RegulationDescription | ProductCode | DeviceClass | Regulation | Panel |
|---|---|---|---|---|
| Glycosylated HemoglobinAssay | LCP | II | 21 CFR864.7470 | Hematology,81 |
| Discrete photometricchemistry analyzer forclinical use | JJE | I | 962.2160 | Chemistry,75 |
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III. PREDICATE DEVICE
The following table identifies the legally marketed device to which Skyla claims equivalence.
Identification of Predicate Device
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) Number | |
| skyla Hi HemoglobinA1c System | Alere Afinion Hba1cand Alere AfinionAS100 Analyzer | Alere Technologies AS | K151809 |
IV. DEVICE DESCRIPTION:
The skyla Hi Analyzer is a portable and compact system, and was designed with skyla Hi Hemoglobin A1c Reagent Kit for on-site quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in human blood.
INDICATIONS FOR USE v.
The skyla Hi Hemoglobin A 1 System, consisting of the skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in venous and finger-stick capillary whole blood
The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus.
This system is intended for clinical laboratory and point-of-care use.
This test is not for screening or diagnosis of diabetes.
VI. COMPARISION OF TECHNOLOGY CHARACTERISTICS WITH THE PRIDICATE DEVICE
Below tables outline the technological characteristics of the skyla Hi Hemoglobin A 1 c System in comparison to the legally marketed predicate devices.
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| Similarities | ||
|---|---|---|
| Item | Candidate Device | Predicate Device |
| skyla HiHemoglobin A1c System | Alere Afinion Hba1c and AlereAfinion AS100 Analyzer | |
| k number | K173127 | K151809 |
| Intended use | The skyla Hi Hemoglobin A1cSystem, consisting of the skyla HiAnalyzer and skyla HiHemoglobin A1c Reagent Kit isan in-vitro diagnostic test forquantitative measurement of thepercent concentration (%) ofglycated hemoglobin (HbA1c %)in venous and finger-stickcapillary whole bloodThe measurement of % HbA1c isused to monitor long-termglycemic control in personspreviously diagnosed withdiabetes mellitus.This system is intended forclinical laboratory and point-of-care use.This test is not for screening ordiagnosis of diabetes. | Alere Afinion™ AS100Analyzer System, consisting ofthe Alere Afinion™ AS100Analyzer or Alere Afinion™AS100 Analyzer Connect andthe Alere Afinion™ TestCartridges, is for in vitrodiagnostic use only. The AlereAfinion™ AS100 AnalyzerConnect comprises of the AlereAfinion™ AS100 Analyzer andthe Alere Afinion™ DataConnectivity Converter.Alere Afinion™ AS100 is acompact multi-assay analyzerfor point-of-care testing. It isdesigned to analyze the AlereAfinion™ Test Cartridges. TheAlere Afinion™ AnalyzerSystem is easy to use, rapid andgives reliable and accurateresults.Alere Afinion™ HbA1c is an invitro diagnostic test forquantitative determination ofglycated hemoglobin(hemoglobin A1c, HbA1c) inhuman whole blood.The measure of HbA1c isrecommended as a marker oflong-term metabolic control inpersons with diabetes mellitus. |
| Type of test | Quantitative in-vitro diagnostictest | Quantitative in-vitro diagnostictest |
| Intended users | Professionals and POC | Professionals and POC |
| Blood sampling | Standard phlebotomy techniquesfor obtaining venous bloodsamples. Fingerstick by use oflancet. | Standard phlebotomy techniquesfor obtaining venous bloodsamples. Fingerstick by use oflancet. |
| Design of sampling device | Collect blood with capillary tube in the reagent pack, and inserting the sampling device into the cartridge | Collect blood with capillary tube in the reagent pack, and inserting the sampling device into the cartridge |
| Cartridge barcode | For cartridge expiration and test lot calibration of HbA1c test | For cartridge expiration and test lot calibration of HbA1c test |
| Differences | ||
| Item | Candidate Device | Predicate Device |
| skyla HiHemoglobin A1c System | Alere Afinion Hba1c andAlere Afinion AS100 Analyzer | |
| Test principle | Immunoturbidimetric assay | Boronate affinity assay |
| Sampling devicecapillary material | Glass | Plastic |
| Fill volume of samplingdevice capillary | $0.8 \mu L$ | $1.5 \mu L$ |
| Time to result | 6 minutes | 3 minutes |
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Skyla Corporation H.S.P.B
VII. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:
Verification and validation activities were performed on skyla Hi hemoglobin A1c System to establish performance, functionality, and reliability of the device system. Evaluations included precision, linearity, interference, sample volume and hematocrit. POC precision data were tabulated below:
| Sample | Site | N | Mean(%) | Repeatability(within run) | BetweenRun | BetweenDay | Total | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| Patient 1(A15) | Site 1 | 80 | 5.04 | 0.097 | 1.9% | 0.000 | 0.0% | 0.032 | 0.6% | 0.103 | 2.0% |
| Site 2 | 80 | 5.06 | 0.082 | 1.6% | 0.039 | 0.8% | 0.034 | 0.7% | 0.097 | 1.9% | |
| Site 3 | 80 | 5.03 | 0.075 | 1.5% | 0.062 | 1.2% | 0.000 | 0.0% | 0.097 | 1.9% | |
| Combined | 240 | 5.04 | 0.085 | 1.7% | 0.038 | 0.8% | 0.014 | 0.3% | 0.095 | 1.9% | |
| Site 1 | 80 | 5.55 | 0.097 | 1.7% | 0.045 | 0.8% | 0.000 | 0.0% | 0.107 | 1.9% |
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Skyla Corporation H.S.P.B
| Patient 2(A12) | Site 2 | 80 | 5.59 | 0.095 | 1.7% | 0.032 | 0.6% | 0.000 | 0.0% | 0.100 | 1.8% |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 3 | 80 | 5.56 | 0.100 | 1.8% | 0.065 | 1.2% | 0.000 | 0.0% | 0.119 | 2.1% | |
| Combined | 240 | 5.56 | 0.097 | 1.7% | 0.049 | 0.9% | 0.000 | 0.0% | 0.110 | 2.0% | |
| Patient 3(A20) | Site 1 | 80 | 6.57 | 0.105 | 1.6% | 0.062 | 0.9% | 0.057 | 0.9% | 0.134 | 2.0% |
| Site 2 | 80 | 6.53 | 0.111 | 1.7% | 0.086 | 1.3% | 0.000 | 0.0% | 0.141 | 2.2% | |
| Site 3 | 80 | 6.54 | 0.110 | 1.7% | 0.057 | 0.9% | 0.040 | 0.6% | 0.130 | 2.0% | |
| Combined | 240 | 6.54 | 0.109 | 1.7% | 0.070 | 1.1% | 0.038 | 0.6% | 0.135 | 2.1% | |
| Patient 4(A24) | Site 1 | 80 | 7.93 | 0.126 | 1.6% | 0.099 | 1.3% | 0.067 | 0.8% | 0.174 | 2.2% |
| Site 2 | 80 | 7.95 | 0.132 | 1.7% | 0.112 | 1.4% | 0.112 | 1.4% | 0.207 | 2.6% | |
| Site 3 | 80 | 7.99 | 0.150 | 1.9% | 0.097 | 1.2% | 0.115 | 1.4% | 0.212 | 2.7% | |
| Combined | 240 | 7.96 | 0.137 | 1.7% | 0.103 | 1.3% | 0.100 | 1.3% | 0.198 | 2.5% | |
| Patient 5(B01-7) | Site 1 | 80 | 12.07 | 0.243 | 2.0% | 0.188 | 1.6% | 0.000 | 0.0% | 0.308 | 2.5% |
| Site 2 | 80 | 12.10 | 0.250 | 2.1% | 0.189 | 1.6% | 0.000 | 0.0% | 0.313 | 2.6% | |
| Site 3 | 80 | 12.13 | 0.212 | 1.7% | 0.138 | 1.1% | 0.096 | 0.8% | 0.270 | 2.2% | |
| Combined | 240 | 12.10 | 0.236 | 2.0% | 0.173 | 1.4% | 0.000 | 0.0% | 0.292 | 2.4% | |
| Control 1(Y1) | Site 1 | 80 | 5.24 | 0.092 | 1.8% | 0.085 | 1.6% | 0.033 | 0.6% | 0.130 | 2.5% |
| Site 2 | 80 | 5.18 | 0.115 | 2.2% | 0.000 | 0.0% | 0.055 | 1.1% | 0.128 | 2.5% | |
| Site 3 | 80 | 5.20 | 0.118 | 2.3% | 0.067 | 1.3% | 0.000 | 0.0% | 0.136 | 2.6% | |
| Combined | 240 | 5.20 | 0.109 | 2.1% | 0.060 | 1.2% | 0.029 | 0.6% | 0.130 | 2.5% | |
| Contro2(Y2) | Site 1 | 80 | 9.70 | 0.200 | 2.1% | 0.142 | 1.5% | 0.143 | 1.5% | 0.284 | 2.9% |
| Site 2 | 80 | 9.71 | 0.208 | 2.1% | 0.022 | 0.2% | 0.096 | 1.0% | 0.230 | 2.4% | |
| Site 3 | 80 | 9.68 | 0.228 | 2.4% | 0.000 | 0.0% | 0.171 | 1.8% | 0.285 | 3.0% | |
| Combined | 240 | 9.69 | 0.213 | 2.2% | 0.052 | 0.5% | 0.140 | 1.4% | 0.260 | 2.7% | |
| Calibrator 1(L5) | Site 1 | 80 | 13.59 | 0.085 | 0.6% | 0.100 | 0.7% | 0.000 | 0.0% | 0.131 | 1.0% |
| Site 2 | 80 | 13.57 | 0.084 | 0.6% | 0.132 | 1.0% | 0.000 | 0.0% | 0.156 | 1.2% | |
| Site 3 | 80 | 13.60 | 0.081 | 0.6% | 0.094 | 0.7% | 0.000 | 0.0% | 0.124 | 0.9% | |
| Combined | 240 | 13.58 | 0.083 | 0.6% | 0.110 | 0.8% | 0.000 | 0.0% | 0.138 | 1.0% |
VIII. Discussion of Clinical Tests Performed:
Method Comparison (POC User Performance Study)
The method comparison study was performed in POC sites by intended operators. It is concluded that either venous whole blood samples or finger-stick capillary samples from candidate device are both comparable to comparative device whole blood testing results.
A total of 243 samples were analyzed. For skyla Hi Hemoglobin A1c System, both venous whole blood sample and finger-stick capillary sample were tested, while for
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Bio-Rad VARIANT II Hemoglobin testing system, only venous whole blood sample was tested.
Result for POC Methoad Comparison Study:
Regression line for venous whole blood: y = 0.9945x + 0.0779
Regression line for finger-stick blood: y = 0.9993x + 0.0589
IX. CONCULSIONS
The clinical and non-clinical tests performed for skyla Hi Hemoglobin A1c System, demonstrate that the test system is safe, effective and substantially equivalent to the legally marketed device identified above.
§ 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).