(511 days)
Tosoh G7
No
The summary describes a device that measures glycated hemoglobin using spectral reflectance. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis focuses on standard analytical performance metrics and comparisons to predicate/reference devices.
No.
The device measures glycated hemoglobin to monitor long-term glucose control, which is a diagnostic function, not a therapeutic one. It provides information for managing a condition, but does not directly treat or prevent it.
Yes
Explanation: The device is intended for the "quantitative measurement of glycated hemoglobin... in monitoring long-term glucose control in individuals with diabetes mellitus," which is a diagnostic purpose.
No
The device description explicitly states the system consists of an "HbA1c Analyzer (MH 200)" and an "HbA1c Test kit," which are hardware components. The analyzer measures the colored responses of the test kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "quantitative measurement of glycated hemoglobin in venous whole blood and capillary fingerstick samples." This involves testing biological samples in vitro (outside the body) to obtain diagnostic information.
- Device Description: The system consists of an analyzer and a test kit, which are typical components of an IVD system used for analyzing biological samples.
- Anatomical Site: The samples are taken from "Venous whole blood and capillary fingerstick samples," which are biological specimens.
- Performance Studies: The document details various analytical performance studies (Precision, Linearity, Analytical Specificity, Detection Limit) and comparison studies (Method comparison, Point-of-Care study, Matrix comparison) conducted to validate the device's performance in analyzing these biological samples. These types of studies are standard for demonstrating the accuracy and reliability of IVD devices.
- Predicate Device: The mention of a predicate device (NycoCard® HbA1c Glycated Hemogiobin Assay) which is also an IVD, further supports the classification of this device as an IVD.
The core function of the LabonaCheck™ A1c is to analyze biological samples (blood) in vitro to provide information about a patient's health status (glycated hemoglobin levels for diabetes monitoring). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LabonaCheck™ Alc consists of LabonaCheck™ Alc HbAlc analyzer and LabonaCheck™ A1c HbA1c Test kit, is for in-vitro diagnostic use only. LabonaCheck TMAIc HbA1c Analyzer is designed to analyze the LabonaCheck™ A1c HbA1c Test Kit.
The LabonaCheck™ AIc is intended for the quantitative measurement of glycated hemoglobin in venous whole blood and capillary fingerstick samples. This device is intended for multiple patient, professional use. Measurement of percent glycated hemoglobin (HbA1c) is effective in monitoring long-term glucose control in individuals with diabetes mellitus by using the LabonaCheck™ Alc. Only auto-disabling, single use lancing devices should be used with this system.
Product codes
LCP
Device Description
The system consists of HbA1c Analyzer (MH 200) and HbA1c Test kit.
The LabonaCheck™ AIc HbAic Analyzer measures the coloured responses of the LabonaCheck™ A1c HbA1c Test Kit by spectral reflectance.
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
multiple patient, professional use.
three point of care sites
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)
Analytical Performance - Precision/Reproducibility:
- Internal study performed at CERAGEM Medisys Inc. with whole blood samples, analyzed across two meters and reagents of two lots.
- External study performed in three point-of-care sites with six operators (two at each site) using three intervals of HbAlc EDTA blood.
Analytical Performance - Linearity/Assay Measuring Range:
- A linearity study across the claimed measuring range (4~15%) was evaluated using low (3.2% HbA1c) and high (17.5% HbA1c) control solutions. Five intermediate levels were created by mixing these solutions.
- The LabonaCheck™ Alc analyzer was used and a second aliquot was analyzed on a reference HbAlc analyzer. Real value was compared to theoretical values based on dilution factor.
- Results support linearity from 4% to 15%.
Analytical Performance - Traceability, Stability, Expected values (controls, calibrators, or methods):
- The LabonaCheck™ Alc device has been certified by the National Glycohemoglobin Standardization Program (NGSP).
Analytical Performance - Detection Limit:
- The Limit of Blank (LoB) and Limit of Detection (LoD) were determined by assaying a zero sample (blank) and five low HbAlc samples according to CLSI guideline EP17-A. Each sample was assayed twice a day in replicates of ten (n=60) for three days.
- Reportable range of 4% to 15% A1c.
Analytical Performance - Analytical Specificity (Interference Study):
- Performed using a protocol based on NCCLS EP7-A to assess common or known interfering substances.
- Interfering substances evaluated in Interval 1 (4.6
6.6), Interval 2 (7.69.6), and Interval 3 (9.8~12.8) of whole blood sample pools. Recovery within 10% of control results was considered non-significant. - No significant interference found for: Ascorbic acid, Bilirubin (Conjugated), Bilirubin (Unconjugated), Glucose, Hemoglobin, Lipid (Triglyceride), Albumin, K3EDTA, Heparin, Sodium fluoride, Sodium citrate, Acetaminophen, Metformin, Acetylsalicylic acid, Glybenclamide, Ibuprofen.
- Hemoglobin variants (F): Bias within ± 10% up to 22.7% HbF. Affected by blood sample containing HbF (>20%).
- Hemoglobin variants (C, D, E, S): Interference testing satisfied acceptance criteria (within ±10% difference to NGSP's data).
- Carbamylated hemoglobin and Rheumatoid factor: Interference testing satisfied acceptance criteria (within ±10% of reference difference compared to Tosoh G7).
Analytical Performance - Hemoglobin Study:
- Performed with 50 whole blood samples (4.6 to 22g/dL HbAlc concentrations).
- Satisfied acceptance criteria (within 10% difference) for hemoglobin concentrations 8.7g/dL to 21.0g/dL.
- Claimed hemoglobin range for measurement is 10.0g/dL - 20.0g/dL. Lower than 10.0g/dL or higher than 20.0g/dL will lead to inaccurate result.
Analytical Performance - Incubation time study:
- Evaluated incubation time between HbAlc in whole blood and R1 reagent.
- Performed 3 measurements using whole blood samples of 3 HbAlc concentrations (Low, Medium, High) for incubation times.
- Incubation for 2 to 3 minutes satisfied acceptance criteria (reference difference within 5%).
Comparison studies - Method comparison with predicate device (Accuracy):
- 50 EDTA venous whole blood patient samples from two point of care sites (25 at each site), spanning 4.2-14.5% HbA1c as measured by reference device.
- Comparison against the predicate device, NycoCard® HbA1c.
- Results:
- Difference between LabonaCheck™A1c and Tosoh G7: 100% (50/50) within ±10%
- Difference between NycoCard and Tosoh G7: 96% (48/50) within ±10%
- Difference between LabonaCheck™A1c and NycoCard: 96% (48/50) within ±10%
- Linear regression and correlation coefficient were calculated.
Comparison studies - Point-of-Care study (Accuracy using venous blood samples):
- 120 EDTA venous whole blood samples in three point of care sites by 6 intended users (two at each site) on one meter. 40 results per site. Samples ranged from 4.5-14.6% as measured by reference device.
- Linear regressions:
- Site 1: Slope 1.0225, Intercept -0.2129, Correlation coefficient 0.9877
- Site 2: Slope 0.9868, Intercept 0.0516, Correlation coefficient 0.9848
- Site 3: Slope 0.9915, Intercept 0.0756, Correlation coefficient 0.9886
- All site combined: Slope 1.0005, Intercept -0.0292, Correlation coefficient 0.9870
Comparison studies - Point-of-Care study (Accuracy using capillary blood samples):
- 120 capillary blood samples in three point of care sites on two meters. 40 results per site. Samples ranged from 4.2% to 14.8% as measured by reference device.
- Linear regressions:
- Site 1: Slope 1.0020, Intercept 0.1670, Correlation coefficient 0.9861
- Site 2: Slope 0.9576, Intercept 0.5119, Correlation coefficient 0.9848
- Site 3: Slope 0.9524, Intercept 0.5584, Correlation coefficient 0.9880
- All site combined: Slope 0.9692, Intercept 0.4230, Correlation coefficient 0.9859
- Key Results: Slope (0.9-1.1), intercept (less than 1%), correlation coefficient results of three POC sites satisfied the acceptance criteria.
Comparison studies - Matrix comparison:
- Venous whole blood samples (K3EDTA, Sodium heparin, NaF) from 40 donors assayed on LabonaCheck™ Alc and compared to reference device (Tosoh G7). Samples ranged from 4.5-14.1%.
- Conclusion: K3EDTA, Sodium heparin, NaF can be used with the device.
- Linear regression analysis performed for K3EDTA vs Sodium Heparin and K3EDTA vs NaF.
Safety and Reliability - Equipment temperature exposure limits:
- Repeatability precision evaluated using three levels of control solutions before and after challenge with temperature change (30±2℃ and 4±2℃).
- No significant difference or tendency observed.
Safety and Reliability - Equipment Humidity exposure limits:
- Evaluated using three levels of control solutions at 80%RH±5 %, 40%RH±5 %, and 10%RH±5 %.
- No significant difference or tendency observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Applicable (as per the document, clinical sensitivity/specificity not applicable).
Predicate Device(s)
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
K IIIII28
SEP
13 2012
510(k) Summary
In accordance with the requirements of 21 CFR.807.92, the following information about 510(k) safety and effectiveness is being submitted.
-
- Submitter
CERAGEMS
- Submitter
MEDISYS
CERAGEM Medisys Inc.
#103-703, SK Ventium, 522 Dangjeong-dong, Gunpo-si, Gyeonggi-do, 435-776, Republic of Korea Phone : (+82) 070-4172-6805 Fax : (+82) 31-455-8822
-
- Date Prepared
August 24, 2012
- Date Prepared
-
- Device Name
Common name : LabonaCheck ™ Alc
- Device Name
Classification : Class II
(Regulation: 21 CFR 864.7470 )
Product Code : LCP (Assay, Glycosylated Hemoglobin)
-
- Predicate Device
The LabonaCheck™ Alc is substantially equivalent to NycoCard® HbAIc described as below.
- Predicate Device
(1) Trade Name: NycoCard® HbA1c Glycated Hemogiobin Assay
- (2) Applicant: Primus Corporation
- (3) 510(K) Number: K993131
- (4) Regulatory Class: II
- (5)-Product-Code:-LCP_
-
- Device Description
The system consists of HbA1c Analyzer (MH 200) and HbA1c Test kit.
The LabonaCheck™ AIc HbAic Analyzer measures the coloured responses of the LabonaCheck™ A1c HbA1c Test Kit by spectral reflectance.
5-1
1
6. Intended Use
CERAGEM
MEDISYS
-
- Intended use(s): See indications for use.
-
- Indication(s) for use
The LabonaCheck™ Alc consists of LabonaCheck™ Alc HbAlc analyzer and LabonaCheck™ A1c HbA1c Test kit, is for in-vitro diagnostic use only. LabonaCheck TMAIc HbA1c Analyzer is designed to analyze the LabonaCheck™ A1c HbA1c Test Kit.
The LabonaCheck™ AIc is intended for the quantitative measurement of glycated hemoglobin in venous whole blood and capillary fingerstick samples. This device is intended for multiple patient, professional use. Measurement of percent glycated hemoglobin (HbA1c) is effective in monitoring long-term glucose control in individuals with diabetes mellitus by using the LabonaCheck™ Alc. Only auto-disabling, single use lancing devices should be used with this system.
| Comparison | ||
|---|---|---|
| Item | Device | Predicate |
| Device Name | LabonaCheck™ A1c | NycoCard® HbA1c |
| Similarities | ||
| Intended Use | The LabonaCheck A1c is an in-vitro diagnostic test for quantitative measurement of glycated hemoglobin (HbA1c) in venous whole blood and capillary fingerstick samples. | The NycoCard HbA1c is a rapid in vitro test for measurement of glycated hemoglobin in human blood. |
| Detection Method | Boronate affinity assay | Boronate affinity assay |
| Analytes | Glycated hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c) |
| Sample Volume | 5 uL | 5 uL |
| Test Time | 3 minutes | 3 minutes |
-
- Comparison to Predicate Device
2
Image /page/2/Picture/0 description: The image shows the logo for CERAGEM MEDISYS. The word "CERAGEM" is in bold, uppercase letters, and the word "MEDISYS" is in smaller, uppercase letters below it. To the right of the words is a geometric design.
| Measuring range | 4 ~ 15% | 4 ~ 15% |
|---|---|---|
| Storage Condition | ||
| (Humidity range) | ||
| (Test kit) | 2~8°C, | |
| (20~70% R.H) | 2~8°C | |
| (Below 70%) | ||
| Warranty | ||
| (Analyzer) | 1 year | 1 year |
| Differences | ||
| Power (Battery) | CR2032 | NiMH |
| Storage Condition | ||
| (Humidity range) | HbA1c Analyzer 10~60°C | |
| (15~75% R.H) | Reader II 2~25°C | |
| (20~70% R.H) |
Conclusion
As the comparison table, the LabonaCheck™ Alc has same intended use, detection method, analytes, same volume, test time, measuring range, storage condition , humidity range (test kit), warranty (analyzer).
To sum up with the similarities, the LabonaCheck™ Alc is similar with the predicate device because most of the specifications deciding the characteristic of the device same.
In conclusion, despite of the difference such as power (battery) and etc., the LabonaCheck™ Alc is substantially equivalent to NycoCard® HbA1c.
8. Performance characteristics
A. Analytical Performance
a. Precision/Reproducibility
Precision studies were conducted internally by the manufacturer and externally at three POC -sites.Precision.studies_were.modeled_from_the NCCLS_guideline_EP5-A2.
Internal study performed at CERAGEM Medisys Inc.
Within-run, day to day and total precision were determined for whole blood samples. Test samples were analyzed per day of each sample using two meter and reagents of two lots.
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Image /page/3/Picture/1 description: The image shows the logo for CERAGEM MEDISYS. The word "CERAGEM" is in bold, block letters, with "MEDISYS" in a smaller font below it. To the right of the text is a geometric design that appears to be a stylized representation of a medical device or technology.
Within-run, day to day and total precision, expressed as Coefficient of Variation (CV) and standard deviation (STD).
| Interval | Reference A1c (%) | Mean(%) | STD | C.V(%) | STD | C.V(%) | STD | C.V(%) |
|---|---|---|---|---|---|---|---|---|
| Within run | Day to day run | Total Precision | ||||||
| 1 | 4.3 | 4.4 | 0.1 | 3.0 | 0.1 | 2.8 | 0.1 | 3.0 |
| 2 | 6.2 | 6.1 | 0.1 | 2.2 | 0.1 | 2.0 | 0.2 | 2.6 |
| 3 | 8.9 | 9.1 | 0.2 | 2.2 | 0.1 | 1.5 | 0.2 | 1.9 |
| 4 | 11.7 | 11.6 | 0.2 | 2.1 | 0.2 | 1.3 | 0.3 | 2.2 |
| 5 | 14.3 | 14.2 | 0.2 | 1.6 | 0.2 | 1.7 | 0.2 | 1.6 |
External study
An external precision study was performed in three point-of-care sites with six operators (two at each site). Three intervals of HbA Ic EDTA blood were analyzed. The results obtained on the A I c for site 1,2,3 are shown in the table below.
| Interval | POC Site 1 | POC Site 1 | POC Site2 | POC Site2 | POC Site3 | POC Site3 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OP1 | OP2 | OP5 | OP6 | OP3 | OP4 | OP1 | OP2 | OP5 | OP6 | OP3 | OP4 | ||
| Mean | 4.8 | 4.8 | 4.9 | 4.9 | 4.8 | 5.0 | 4.9 | 4.9 | 4.9 | 4.9 | 4.9 | 4.9 | |
| STD | 0.14 | 0.15 | 0.16 | 0.16 | 0.14 | 0.16 | 0.14 | 0.16 | 0.16 | 0.15 | 0.17 | 0.15 | |
| C.V (%) | 2.9 | 3.2 | 3.3 | 3.3 | 2.9 | 3.2 | 2.9 | 3.3 | 3.3 | 3.1 | 3.5 | 3.1 | |
| I | Mean | 4.8 | 4.9 | 4.9 | 4.9 | 4.9 | 4.9 | ||||||
| STD | 0.15 | 0.16 | 0.17 | 0.15 | 0.16 | 0.16 | |||||||
| C.V (%) | 3.0 | 3.2 | 3.4 | 3.1 | 3.2 | 3.3 | |||||||
| Mean | 4.8 | 4.9 | 4.9 | ||||||||||
| STD | 0.16 | 0.16 | 0.16 | ||||||||||
| C.V (%) | 3.2 | 3.4 | 3.3 | ||||||||||
| 2 | Mean | 8.9 | 8.7 | 8.8 | 8.8 | 8.8 | 8.9 | 8.8 | 8.8 | 8.8 | 8.6 | 8.8 | 8.8 |
| STD | 0.25 | 0.29 | 0.29 | 0.28 | 0.29 | 0.26 | 0.26 | 0.23 | 0.28 | 0.26 | 0.32 | 0.28 | |
| C.V (%) | 2.8 | 3.3 | 3.3 | 3.2 | 3.3 | 2.9 | 2.9 | 2.7 | 3.2 | 3.0 | 3.6 | 3.1 | |
| Mean | 8.8 | 8.8 | 8.9 | 8.8 | 8.7 | 8.8 | |||||||
| STD | 0.28 | 0.29 | 0.29 | 0.25 | 0.28 | 0.30 | |||||||
| C.V (%) | 3.2 | 3.2 | 3.2 | 2.8 | 3.2 | 3.4 |
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Image /page/4/Picture/0 description: The image shows the logo for CERAGEM MEDISYS. The word "CERAGEM" is in bold, uppercase letters. Below it, the word "MEDISYS" is in smaller, uppercase letters. To the right of the words is a geometric design.
| Mean | 8.8 | 8.8 | 8.7 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| STD | 0.28 | 0.27 | 0.29 | ||||||||||
| C.V (%) | 3.2 | 3.0 | 3.3 | ||||||||||
| Mean | 13.1 | 13.3 | 13.1 | 13.3 | 13.3 | 13.1 | 13.3 | 13.1 | 13.5 | 13.2 | 13.5 | 13.2 | |
| STD | 0.42 | 0.42 | 0.43 | 0.44 | 0.36 | 0.43 | 0.37 | 0.41 | 0.44 | 0.46 | 0.45 | 0.44 | |
| C.V (%) | 3.2 | 3.1 | 3.3 | 3.3 | 2.7 | 3.3 | 2.8 | 3.1 | 3.2 | 3.5 | 3.3 | 3.4 | |
| 3 | Mean | 13.2 | 13.2 | 13.2 | 13.2 | 13.3 | 13.3 | ||||||
| STD | 0.44 | 0.44 | 0.41 | 0.41 | 0.47 | 0.46 | |||||||
| C.V (%) | 3.3 | 3.3 | 3.1 | 3.1 | 3.5 | 3.4 | |||||||
| Mean | 13.2 | 13.2 | 13.3 | ||||||||||
| STD | 0.43 | 0.41 | 0.46 | ||||||||||
| C.V (%) | 3.3 | 3.1 | 3.5 |
b. Linearity/Assay Measuring Range
A linearity study across the entire clamed measuring range (4~15%) was evaluated using low (3.2% HbA1c) and high (17.5% HbA1c) control solutions. The low and high control solutions were mixed together in ratios to make five intermediate levels. The control solutions were mixed well and divided into two aliquots. One aliquot was used to perform on the LabonaCheck™ Alc analyzer and the second aliquot was analyzed on the reference HbAlc analyzer. Real value was compared to the theoretical values based upon the dilution factor. The % recovery was calculated with the following formula: Recovery = Real value / Expected % x 100. The percent recovery between the real values verses the expected values are shown in the table below :
| Sample
| No. | Expected (%) | Real Value (%) | Difference (%) | % Recovery |
|---|---|---|---|---|
| 1 | 3.2 | 3.5 | 0.3 | 108 |
| 2 | 5.6 | 5.8 | 0.2 | 103 |
| 3 | 8.0 | 8.1 | 0.1 | 101 |
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Image /page/5/Picture/1 description: The image shows the logo for CERAGEM MEDISYS. The text "CERAGEM" is in bold, uppercase letters on the top line. Below that, the text "MEDISYS" is in smaller, uppercase letters. To the right of the text is a geometric design.
| 4 | 10.4 | 10.5 | 0.1 | 101 |
|---|---|---|---|---|
| 5 | 12.7 | 12.9 | 0.2 | 102 |
| 6 | 15.1 | 15.4 | 0.3 | 102 |
| 7 | 17.5 | 17.5 | 0 | 100 |
The results of the study support the sponsor's claimed that LabonaCheck™ Alc is linear from 4% to 15%.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The LabonaCheck™ Alc device has been certified by the National Glycohemoglobin Standardization Program (NGSP). NGSP certifications are renewed annually. Current NGSP certifications are found on the web at http://www.ngsp.org/prog/index.html
d. Detection Limit
The !imit of Blank (LoB) and Limit of Detection (LoD) were determined by assaying a zero sample (blank) and five low HbAlc samples according to CLSI guideline EP17-A. A zero sample was Negative or very low concentration sample that is commutable with patient specimen. Each sample was assayed twice a day in replicates of ten (n=60) for three days on the LabonaCheck™ A1c.The detection limits were summarized in the table below :
(Ng=60, Ns=60)
| Blank(%) | Low concentration (%) | |
|---|---|---|
| Mean % | 3.10 | 4.12 |
| SD | 0.080 | 0.092 |
This assay has reportable range of 4% to 15% A1c.
6
ERAGEM MEDISYS
e. Analytical Specificity
Interference Study: Interference testing was performed using a protocol based on NCCLS EP7-A. Studies were performed to assess common or known substances that could interfere with the LabonaCheck™ AIc. The interfering substances were evaluated in Interval 1 (4.66.6), Interval 2 (7.69.6), and Interval 3 (9.8~12.8). Three intervals of whole blood sample pools were spiked with interfering substance. The sponsor states that recovery within 10% of the control results was considered to be non-significant. The following compounds, at the levels indicated, were shown to have no significant interference on the LabonaCheck™ A1c test results : Ascorbic acid: 6mg/dL, Bilirubin (Conjugated): Smg/dL, Bilirubin (Unconjugated): 5mg/dL, Glucose: 1200mg/dL, Hemoglobin: 20g/dL, Lipid (Triglyceride): 500mg/dL, Albumin: 5g/dL, K3EDTA: 300 mg/dL, Heparin: 8000 U/dL, Sodium fluoride: 1000 mg/dL, Sodium citrate: 3.20%, Acetaminophen: 30 mg/dL, Metformin: 4 mg/dL, Acetylsalicylic acid: 1000mg/dL, Glybenclamide: 5 mg/dL, Ibuprofen: 40 mg/dL.
To evaluate the effect of Hemoglobin variants (F), Sponsor performed the testing using samples (HbF: 22.3~27.8%) provided by the NGSP. When sponsor compared between test result of candidate device and result of reference device, the average bias caused by the hemoglobin F sample were within ± 10% up to 22.7%. Therefore, sponsor claimed the test results of candidate device is affected by blood sample containing HbF (>20%).
To evaluate the effect of Hemoglobin variants (C, D, E, and S), Sponsor performed the testing using samples provided by the NGSP known to contain variants C, D, E, and, S on the LabonaCheck™ A1c. The results of LabonaCheck™ A1c were compared to NGSP's data (results of Primus). The sponsor's acceptance criteria was within ±10% of reference difference to be considered as no significant interference. Interference testing about Hemoglobin C, D, E, and S satisfied acceptance criteria.
NGSP has hemoglobin variants interference information for method at http://www.ngsp.org/prog/index.html
To evaluate the effect of Carbamylated hemoglobin and Rheumatoid factor, Sponsor
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Image /page/7/Picture/1 description: The image contains the logo for CERAGEM MEDISYS. The text "CERAGEM" is in a bold, sans-serif font, with "MEDISYS" in a smaller font size directly below it. To the right of the text is a stylized graphic element, possibly representing a medical device or technology.
performed the testing using 10 samples on the LabonaCheck™ A1c and reference device (Tosoh G7). The sponsor's acceptance criteria was within ±10% of reference difference to be considered as no significant interference. Interference testing about Carbamylated hemoglobin and Rheumatoid factor satisfied acceptance criteria.
r
| Carbamylated hemoglobin | Rheumatiod factor | |
|---|---|---|
| Control sample | Whole blood sample | Whole blood sample |
| Test sample 1 | ||
| (Low) | Whole blood sample + | |
| $2.5 \text{ mmol/L of sodium cyanate}$ | Whole blood sample + | |
| $100 \text{ IU/mL of rheumatoid factor}$ | ||
| Test sample 2 | ||
| (High) | Whole blood sample + | |
| $5 \text{ mmol/L of sodium cyanate}$ | Whole blood sample + | |
| $300 \text{ IU/mL of rheumatoid factor}$ |
Hemoglobin Study: The hemoglobin study was performed with 50 whole blood samples. We selected samples ranged from 4.6 to 22g/dL over a wide range of HbAIc concentrations. According to the results, LabonaCheckTM A1c satisfied the acceptance criteria (within 10% difference) at hemoglobin concentrations ranged from 8.7g/dL to 21.0g/dL. Sponsor claimed that the hemoglobin range for HbA1c measurement of the LabonaCheckTMA1c is 10.0g/dL -20.0g/dL. Lower than 10.0g/dL or higher than 20.0g/dL of hemoglobin concentration will lead to inaccurate result.
Image /page/7/Figure/5 description: The image shows a scatter plot titled "Effect of Hemoglobin concentration". The x-axis represents Hb Concentration in g/dL, ranging from 0.0 to 25.0. The y-axis represents the % Difference, ranging from -30.0% to 30.0%. The scatter plot shows the relationship between hemoglobin concentration and percentage difference, with data points clustered around the center.
8
MEDISYS Incubation time study: The purpose of this testing is to evaluate incubation time between HbAlc in whole blood and R1 reagent have an effect on the LabonaCheck™ A1c. Each meter were performed 3 measurements using whole blood samples of 3 HbAlc concentrations (Low, Medium, High) for incubation times. According to test result, when R1 reagent and the whole blood sample incubated for 2 to 3 minutes, reference difference was
within 5%. Incubated samples for 2 minutes to 3minutes were satisfied acceptance criteria.
f. Assay cut-off
CERAGEM
Not applicable.
B. Comparison studies
a. Method comparison with predicate device
Accuracy: A method comparison study was performed with performed with 50 EDTA venous whole blood patient samples in two point of care sites (two at each site). The testing was performed by comparing the venous whole blood results of 50 samples (25 at each site) that spanned the claimed assay range to the results obtained by the predicate device, NycoCard® HbA1c. Samples ranged from 4.2-14.5 as measured by the reference device. The difference % are as follows:
| | Difference between
LabonaCheck™A1c and
Tosoh G7 | Difference between
NycoCard and Tosoh G7 | Difference between
LabonaCheck™A1c and
NycoCard |
|-----------------|-------------------------------------------------------|---------------------------------------------|-------------------------------------------------------|
| within
± 10% | 100%
(50/50) | 96%
(48/50) | 96%
(48/50) |
.The .linear_regression.and.correlation.coefficient.are.as follow:
| Slope | Intercept | Correlation coefficient | |
|---|---|---|---|
| LabonaCheck vs Tosoh G7 | 1.0552 | -0.4360 | 0.9708 |
| NycoCard vs Tosoh G7 | 1.0613 | -0.3304 | 0.9695 |
9
| CERAGEM
MEDISYS | | | CERAGEM Medisys Inc.
www.ceragemmedisys.com | | |
|--------------------|-------------------------|--------|------------------------------------------------|--------|--|
| | LabonaCheck vs NycoCard | 0.9873 | -0.0516 | 0.9873 | |
b. Point-of-Care study
Accuracy (using venous blood samples): POC study was performed with 120 EDTA venous whole blood samples in three point of care sites by 6 intended users (two at each site) on one meters. Total of 120 measurements are obtained (40 results of testing at each site) samples ranged from 4.5-14.6 as measured by the reference device. The linear regressions are as follows:
| Slope | Intercept | Correlation coefficient | |
|---|---|---|---|
| (95% confidence interval) | |||
| Site 1 | 1.0225 | ||
| (0.9850~1.0600) | -0.2129 | ||
| (-0.5291~-0.1034) | 0.9877 | ||
| Site 2 | 0.9868 | ||
| (0.9466~1.0271) | 0.0516 | ||
| (-0.2768~-0.3801) | 0.9848 | ||
| Site 3 | 0.9915 | ||
| (0.9565~1.0265) | 0.0756 | ||
| (-0.2172~-0.3683) | 0.9886 | ||
| All site combined | 1.0005 | ||
| (0.9796~1.0215) | -0.0292 | ||
| (-0.2036~-0.1451) | 0.9870 |
Accuracy (using capillary blood samples): POC study was performed with 120 capillary blood samples in three point of care sites on two meters. Total of 120 measurements are obtained (40 result of testing at each site) samples ranged from 4.2 %to 14.8 % as measured by the reference device. The linear regressions are as follows:
| Slope | Intercept | Correlation coefficient | |
|---|---|---|---|
| (95% confidence interval) | |||
| Site 1 | 1.0020 | 0.1670 | 0.9861 |
| (0.9629~1.0411) | (-0.4805~0.1465) | ||
| Site 2 | 0.9576 | 0.5119 | 0.9848 |
| (0.9185~0.9967) | (0.1959~0.8280) |
10
| CERAGEM
MEDISYS | | | | CERAGEM Medisys Inc.
www.ceragemmedisys.com |
|----------------------|------------|-----------------|-----------------|------------------------------------------------|
| | | 0.9524 | 0.5584 | 0.9880 |
| Site 3 | | (0.91800.9869) | (0.27730.8396) | |
| All site
combined | Site 1+2+3 | 0.9692 | 0.4230 | 0.9859 |
| | | (0.94810.9903) | (0.25230.5937) | |
According to the above results, the slope (0.9-1.1), intercept (less than 1%), correlation coefficient results of three POC sites satisfied the acceptance criteria.
c. Matrix comparison
Venous whole blood samples (K3EDTA, Sodium heparin, NaF) collected from 40 donors were assayed on the LabonaCheck™ Alc and compared to the reference device (Tosoh G7). Samples ranged from 4.5-14.1%. The results of the studies are presented below:
(1) Linear regression analysis
| Slope | Intercept | Correlation coefficient | ||
|---|---|---|---|---|
| (95% confidence interval) | ||||
| Result 1 | 0.9661 | 0.2442 | 0.9685 | |
| K3EDTA | ||||
| vs | ||||
| Sodium Heparin | (0.9088~1.0234) | (-0.2949-0.7833) | ||
| Result 2 | 0.9721 | 0.3790 | 0.9681 | |
| (0.9140~1.0301) | (-0.1587-0.9166) | |||
| Result 1+2 | 0.9682 | 0.3190 | 0.9670 | |
| (0.9279~1.0085) | (-0.0570-0.6951) | |||
| Result 1 | 0.9486 | 0.3807 | 0.9579 | |
| (0.8834-1.0139) | (-0.2332-0.9946) | |||
| K3EDTA | ||||
| vs | ||||
| NaF | 0.9498 | 0.4832 | ||
| Result 2 | (0.8834~1.0162) | (-0.1318-1.0983) | 0.9567 | |
| 0.9487 | 0.4364 | |||
| Result 1+2 | (0.9033-0.9941) | (0.0127-0.8602) | 0.9569 |
11
Alc: The sponsor concluded that the following anticoagulants can be used with their Alc device: K3EDTA, Sodium heparin, NaF.
C. Safety and Reliability
Equipment temperature exposure limits: Repeatability precision using three levels of control solutions was evaluated before and after challenge with temperature change. The testing degrees of high temperature limits were 30±2℃, and testing degrees of low temperature limits were 4±2℃.
There is no significant difference or tendency between the each test result measured on the each condition, 4℃ and 30℃, on LabonaCheck™ Alc.
Equipment Humidity exposure limits: The humidity test was evaluated using three levels of control solutions. The testing degrees of high humidity were 80%RH±5 %, and the testing degrees of normal humidity limits were 40%RH±5 %, and the testing degrees of fow humidity were 10%RH±5 %. There is no significant difference or tendency on the each test result at 10%RH, 40%RH, and 80%RH.
D. Clinical studies
- Clinical sensitivity (1) Not Applicable
- (2) Clinical specificity: Not Applicable
- Other clinical supportable data(when a and b are not applicable) (3) Not Applicable
- E .- Clinical-cut-off:
Not Applicable
F. Appendix
12
Image /page/12/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a modern, abstract representation of a human figure, possibly suggesting care and support.
10903 New Hampshire Avenue Silver Spring, MD 20993
CERAGEM International c/o Raymond Chung 3699 Wilshire Blvd., Suite 930 Los Angeles, CA 90010
SEP 1 3 2012
Re: k11128 Trade Name: LabonaCheck™ Alc Regulation Number: 21 CFR §864.7470 Regulation Name: Quantitative, Hemoglobin Alc Test System Regulatory Class: Class II Product Codes: LCP Dated: September 4, 2012 Received: September 10, 2012
Dear Raymond Chung:
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 (see 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).
13
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire speeding and your stic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) proase note the regarding postmarket surveillance, please contact CDRH 's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of but vemance and garding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.html
Sincerely yours,
N. K. Jain, Ph.D.
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
14
Indication for Use
510(k) Number (if known): K111128
Device Name: LabonaCheck™ A1c
Indication For Use:
The LabonaCheck™ A1c is intended for the quantitative measurement of glycated hemoglobin in venous whole blood and capillary fingerstick samples. This device is intended for multiple patient, professional use. Measurement of percent glycated hemoglobin (HbA 1c) is effective in monitoring long-term glucose control in individuals with diabetes mellitus by using the LabonaCheck™ A1c. Only auto-disabling, single use lancing devices should be used with this system.
Prescription Use 4 (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use __ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Kattar Lussier
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 11112 B