(268 days)
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No
The summary describes a standard in vitro diagnostic assay for measuring glycated albumin using liquid reagents and a clinical chemistry analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on analytical characteristics like precision, linearity, and interference, which are standard for such assays.
No
The device is an in vitro diagnostic (IVD) test used for quantitative measurement of glycated albumin. It is used for monitoring glycemic control in patients with diabetes, but it does not directly treat or cure any condition.
Yes
The intended use explicitly states, "For in vitro diagnostic use only," and the device measures glycated albumin for "monitoring of glycemic control in patients with diabetes," which is a diagnostic purpose.
No
The device description clearly states it contains "two glycated albumin reagents and two albumin reagents" and is a "kit." This indicates it is a physical in vitro diagnostic (IVD) kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is the primary indicator that the device is intended for use in diagnosing diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
Furthermore, the description of the device and its intended use aligns with the definition of an IVD:
- Measures a substance in human serum: Glycated albumin is measured in a biological sample (serum).
- Used for monitoring a medical condition: It's used for monitoring glycemic control in patients with diabetes.
- Used on clinical chemistry analyzers: This indicates it's used in a laboratory or clinical setting.
N/A
Intended Use / Indications for Use
The Lucica® Glycated Albumin-L is intended to be used for the quantitative measurement of glycated albumin in human serum on compatible clinical chemistry analyzers. The measurement of glycated albumin is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes. For in vitro diagnostic use only.
Product codes
LCP
Device Description
Lucica® Glycated Albumin-L contains two glycated albumin reagents and two albumin reagents. The kit employs liquid reagents that require no preparation. Calibrators are supplied by Asahi Kasei Pharma Corporation to calibrate the Lucica® Glycated Albumin-L. The calibrators are available in two concentrations, Low (L) and High (H). The user should refer to the instrument operations manual for analyzer-specific calibration procedures. Controls are supplied by Asahi Kasei Pharma Corporation for use with the Lucica® Glycated Albumin-L. The controls are available in two concentrations, Low (L) and High (H).
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
Prescription 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
Analytical Performance:
- Precision/Reproducibility:
- Single site: Five serum sample pools were tested twice per run, two runs per day, for 20 testing days (N=80). Repeatability (%CV) was not more than 2.6% and within-laboratory precision (%CV) was not more than 3.3%.
- Multisite: Three serum sample pools were tested at three different laboratories, five replicates per run, one run per day, for five testing days (N=25). Overall reproducibility of glycated albumin values was not more than 1.6% CV.
- Linearity: Study performed according to CLSI Guideline EP6-A using lowest and highest GA value serum sample pools mixed in varying ratios. Samples were analyzed in triplicate in one run. The study supported that the GA value is linear across the range of 173 to 979 mmol/mol.
- Traceability: Established in accordance with "Committee on Diabetes Mellitus Indices of the Japan Society of Clinical Chemistry-recommended reference measurement procedure and reference materials for glycated albumin determination". Validation was performed using the Manufacturer's Product Calibrator and Control, traceable to Secondary Calibrators (Glycated Albumin Certified Material, JCCRM 611-1, M, H, HH).
- Stability:
- Reagent shelf-life: 12 months when refrigerated between 2 and 8 °C.
- Open reagent stability: 1 month in Modular P reagent cabinet.
- Calibrator shelf-life: 12 months when stored at or below 8 °C.
- Calibrator in-use stability (reconstituted): 2 weeks when stored at or below 8 °C.
- Control shelf-life: 12 months when stored at or below 8 °C.
- Control in-use stability (reconstituted): 1 month when stored at or below 8 °C.
- Limit of detection: Performed according to CLSI Guideline EP17-A2.
- LoB for GA: 6.9 µmol/L, for albumin: 3.8 µmol/L.
- LoD for GA: 7.9 µmol/L, for albumin: 7.0 µmol/L.
- LoQ for GA: 9.7 µmol/L, for albumin: 21.8 µmol/L.
- Interference Studies: Performed according to CLSI Guideline EP7-A2.
- No significant interference (bias
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, with its arms outstretched.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 12, 2017
ASAHI KASEI PHARMA CORPORATION C/O CHRIS SLOAN QUINTILESIMS 1801 ROCKVILLE PIKE, SUITE 300 ROCKVILLE MD 20852
Re: K170147
Trade/Device Name: Lucica Glycated Albumin-L Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP Dated: September 12, 2017 Received: September 12, 2017
Dear Chris Sloan:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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) K170147
Device Name Lucica® Glycated Albumin-L
Indications for Use (Describe)
The Lucica® Glycated Albumin-L is intended to be used for the quantitative measurement of glycated albumin in human serum on compatible clinical chemistry analyzers. The measurement of glycated albumin is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes. For in vitro diagnostic use only.
| 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 FOR K170147
Lucica® Glycated Albumin-L
510(k) Owner
Asahi Kasei Pharma Corporation 1-105 Kanda Jinbocho, Chiyoda-ku Tokyo 101-8101 JAPAN Contact Person: Hideji Hiraoka, Manager of US region, Global Marketing Group Phone: +81-3-3296-3617 Fax: +81-3-3296-3682 E-mail: hiraoka.hb@om.asahi-kasei.co.jp
Official Correspondent
Christopher Sloan Principal Consultant QuintilesIMS 1801 Rockville Pike, Suite 300 Rockville, MD 20852 Phone: +1-301-272-3114 E-mail: chris.sloan@quintilesims.com
Date Prepared: October 9, 2017
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Subject Device Name:
| Trade Names | Lucica® Glycated Albumin-L |
|---|---|
| Common or usual name | Glycated albumin assay |
Regulatory Information
| Regulation Description | Product Code | Device Class | Regulation Number | Classification Panel |
|---|---|---|---|---|
| Glycosylated Hemoglobin Assay | LCP | II | 21 CFR 864.7470 | Hematology (81) |
Submission Type: Traditional 510(k)
Predicate Device
The Lucica® Glycated Albumin-L is equivalent to the following FDA-cleared assay:
- Fructosamine Test Kit [Randox Laboratories, Ltd (K023763) ●
Device Description
Lucica® Glycated Albumin-L:
Lucica® Glycated Albumin-L contains two glycated albumin reagents and two albumin reagents. The kit employs liquid reagents that require no preparation.
Calibrator for Lucica® Glycated Albumin-L:
Calibrators are supplied by Asahi Kasei Pharma Corporation to calibrate the Lucica® Glycated Albumin-L. The calibrators are available in two concentrations, Low (L) and High (H). The user should refer to the instrument operations manual for analyzer-specific calibration procedures.
Control for Lucica® Glycated Albumin-L:
Controls are supplied by Asahi Kasei Pharma Corporation for use with the Lucica® Glycated Albumin-L. The controls are available in two concentrations, Low (L) and High (H).
Indications for Use
The Lucica Glycated Albumin-L is intended to be used for the quantitative measurement of glycated albumin in human serum on compatible clinical chemistry analyzers. The
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measurement of glycated albumin is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes. For in vitro diagnostic use only.
Comparison of Intended Use / Indications for Use and Technological Characteristics to Predicate Device
| | Lucica® Glycated Albumin-L | Randox Fructosamine
Test Kit (K023763)
(Predicate) | Substantial
Equivalence |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| REAGENT
KIT
Intended Use /
Indications for
Use | The Lucica® Glycated Albumin-
L is intended to be used for the
quantitative measurement of
glycated albumin in human
serum on compatible clinical
chemistry analyzers. The
measurement of glycated
albumin is useful for the
intermediate term (preceding 2-3
weeks) monitoring of glycemic
control in patients with diabetes.
For in vitro diagnostic use only. | The Randox Laboratories
Limited Fructosamine test kit
is an in vitro diagnostic
enzymatic assay for the
quantitative determination of
glycated protein
(fructosamine) in human
serum or plasma.
Measurement of glycated
serum protein is
representative of the mean
blood glucose levels over the
preceding 2-3 weeks.
For in vitro diagnostic use
only. | Yes |
| Sample Type | Serum | Serum or plasma | Yes |
| Methodology | Enzymatic assay | Enzymatic assay | Yes |
Table 1 Comparison of Assays
Performance Testing
The following data represent the typical performance of Lucica® Glycated Albumin-L. The data were collected on the FDA-cleared Roche/Hitachi Modular P Chemistry system.
1. Analytical Performance:
a. Precision/Reproducibility
A precision study of the Lucica® Glycated Albumin-L was performed according to CLSI Guideline EP05-A3.
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Single site: Repeatability and within-laboratory precision was established by testing five serum sample pools. Each sample was assayed twice per run, two runs per day, for 20 testing days (N=80). The repeatability and within-laboratory precision of glycated albumin values in Lucica® Glycated Albumin-L expressed in %CV were not more than 2.6% and 3.3%, respectively. The results are summarized in Table 2.
| Sample | Target Value
(mmol/mol) | Mean
(mmol/mol) | N | Repeatability | | Within-Laboratory | |
|--------------|----------------------------|--------------------|----|---------------|-----|-------------------|-----|
| | | | | %CV | SD | %CV | SD |
| Pool serum 1 | 183 | 185.2 | 80 | 1.7% | 3.1 | 2.2% | 4.0 |
| Pool serum 2 | 224 | 228.0 | 80 | 0.8% | 1.7 | 1.1% | 2.6 |
| Pool serum 3 | 355 | 359.9 | 80 | 0.7% | 2.6 | 0.9% | 3.2 |
| Pool serum 4 | 863 | 877.7 | 80 | 0.8% | 7.0 | 0.9% | 7.8 |
| Pool serum 5 | 226 | 229.6 | 80 | 2.6% | 6.0 | 3.3% | 7.6 |
Table 2 Single Site Precision Summary Table of Glycated Albumin Values (mmol/mol)
Abbreviations: %CV, coefficient of variation expressed as a percentage; SD, standard deviation
Multisite: Multisite (3 sites) precision was established by testing three serum sample pools at three different laboratories. Each sample was assayed five replicates per run, one run per day, for five testing days (N=25). In the multisite precision study, the overall reproducibility of glycated albumin values were not more than 1.6% CV. The results are summarized in Table 3.
Table 3 Summary of the Multisite Precision Study (overall) of Glycated Albumin Values (mmol/mol)
| Sample | N | Target Value | Mean | Repeatability | | Within-
Laboratory | | Reproducibility | |
|--------------|----|--------------|-------|---------------|------------|-----------------------|-----|-----------------|-----|
| | | | | (mmol/mol) | (mmol/mol) | %CV | SD | %CV | SD |
| Pool serum 1 | 75 | 183 | 187.7 | 0.8% | 1.6 | 1.0% | 1.9 | 1.6% | 3.0 |
| Pool serum 2 | 75 | 355 | 363.1 | 0.7% | 2.7 | 0.9% | 3.2 | 0.9% | 3.2 |
| Pool serum 3 | 75 | 863 | 888.2 | 0.7% | 6.4 | 0.8% | 7.4 | 0.9% | 8.2 |
Abbreviations: %CV, coefficient of variation expressed as a percentage; SD, standard deviation
b. Linearity
The linearity study of the Lucica® Glycated Albumin-L was performed according to CLSI Guideline EP6-A. The linearity study of the glycated albumin (GA) value used a lowest and a highest GA value serum sample pools. These samples were mixed together in varying ratios. Samples were analyzed in triplicate in one run. The study supported that the GA value is linear across the range of 173 to 979 mmol/mol.
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c. Traceability
The traceability system was established in accordance with "Committee on Diabetes Mellitus Indices of the Japan Society of Clinical Chemistry-recommended reference measurement procedure and reference materials for glycated albumin determination". Validation of value assignment of Calibrator and Control were performed using the Manufacturer's Product Calibrator and Control, which rank the lowest in the traceability system. Each of the Secondary Calibrators (Glycated Albumin Certified Material, JCCRM 611-1, M, H, HH) were measured and the results showed that the Calibrator and Control for Lucica® Glycated Albumin-L were traceable to the secondary calibrator.
d. Stability
Reagent: The shelf-life for the Lucica® Glycated Albumin-L reagents was 12 months when refrigerated within a temperature range between 2 and 8 °C. The open reagent stored in the Modular P reagent cabinet was stable for 1 month.
Calibrator: The shelf life for Calibrator for Lucica® Glycated Albumin-L was 12 months when stored at or below 8 °C. In-use stability of the Calibrator for Lucica® Glycated Albumin-L after reconstitution was stable for 2 weeks when stored at or below 8 °C.
Control: The shelf life for Control for Lucica® Glycated Albumin-L was 12 months when stored at or below 8 °C. The in-use stability of Control for Lucica Glycated Albumin-L after reconstitution was set at 1 month when stored at or below 8 ℃.
e. Limit of detection
The Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) studies of the Lucica® Glycated Albumin-L were performed according to CLSI Guideline EP17-A2.
The LoB, LoD, and LoO for GA and ALB concentration were determined in the table below.
Table 4
| | Concentration of GA
(µmol/L) | Concentration of albumin
(µmol/L) |
|-----|---------------------------------|--------------------------------------|
| LoB | 6.9 | 3.8 |
| LoD | 7.9 | 7.0 |
| LoQ | 9.7 | 21.8 |
The LoB, LoD, and LoQ for GA and ALB concentration
f. Interference Studies
The interference study of the Lucica Glycated Albumin-L was performed according to CLSI Guideline EP7-A2. To obtain high level test samples, two base serums with two GA value levels (Normal pool serum and DM serum) were spiked with high concentration stock solutions of the potential interfering substances. Control samples were obtained similarly by
8
adding a solvent instead of a stock solution. Next, test samples with six total different concentration levels were prepared by mixing control samples and high level test samples.
The assay was considered to have no significant interference if the bias between controls and samples containing interferent did not exceed 10%.
| Compounds | Concentration of no significant
interference | |
|----------------------|-------------------------------------------------|-------------|
| Endogenous compounds | | |
| 1 | Unconjugated bilirubin | 20.0 mg/dL |
| 2 | Conjugated bilirubin | 20.0 mg/dL |
| 3 | Hemoglobin | 288 mg/dL |
| 4 | Glucose | 1,000 mg/dL |
| 5 | Ascorbic Acid | 100 mg/dL |
| 6 | Triglycerides | 1,516 mg/dL |
| 7 | Uric Acid | 23.5 mg/dL |
Interference study of Lucica® Glycated Albumin-L Table 5
Hemoglobin at 384 mg/dL decreases the glycated albumin value in serum at 240 mmol/mol by 12.9%, and at 467 mmol/mol by 9.9%.
Triglycerides at 2,004 mg/dL decreases the glycated albumin value in serum at 232 mmol/mol by 11.6%, and at 467 mmol/mol by 2.6%.
Low and high albumin and total protein concentrations had no significant interference effect on performance of the Lucica® Glycated Albumin-L assay.
2. Outcomes
There is peer-reviewed literature supporting the use of glycated albumin (GA) as a good marker of glycemic control based on clinical outcomes, for microvascular complications, macrovascular complications, diabetes risk, prognosis in hemodialysis patients and predicting pregnancy outcomes. GA has been shown to be useful for the intermediate term monitoring of glycemic control in patients with diabetes.
For microvascular complications, studies involving collectively over 11.000 subjects in the US1/2 and in China , followed for 5 to 20 years revealed that GA is associated with the onset and progression of diabetic microvascular complications.
For macrovascular complications, studies in the US4, Japan3, Korea877 and China9 involving collectively over 11,000 subjects revealed that GA is associated with vascular outcomes, atherosclerosis, poor prognosis and mortality.
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3. Reference Range Study
The reference range of Lucica® Glycated Albumin-L for healthy non-diabetic subjects in the US was developed. The glycated albumin value in 262 healthy non-diabetic subjects ranged between 183 and 259 mmol/mol.
Conclusion
The results of performance and clinical testing demonstrate that the Lucica® Glycated albumin-L is substantially equivalent to glycosylated hemoglobin assays cleared under 21 CFR 864.7470 (class II; product code LCP) including the Randox Laboratories, Inc. Fructosamine assay, cleared under K023763.
References:
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- Nathan DM, McGee P, Steffes MW, et al. Diabetes. 2014; 63(1): 282-290
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- Selvin E et al., Lancet Diabetes Endocrinol. 2014; 2(4): 279-88
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- Pan J et al. J Diabetes Complic. 2014; 772-778.
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- Selvin E, Rawlings AM, Lutsey PL, et al. Circulation. 2015; 269-277
-
- Mukai N et al., Cardiovasc Diabetol. 2015 Jun 24; 14: 84.
-
- Song SO et al., Atherosclerosis. 2012 Dec; 225(2): 450-5.
-
- Yoon HJ et al., Cardiovasc Diabetol. 2015 May 15; 14: 53.
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- Yang ZK, et al. Int J Cardiol. 2015 Oct 15; 197: 241-7.