(268 days)
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.
Lucica® Glycated Albumin-L contains two glycated albumin reagents and two albumin reagents. The kit employs liquid reagents that require no preparation.
The document describes the analytical performance and clinical utility of the Lucica® Glycated Albumin-L device, which is an in vitro diagnostic test for measuring glycated albumin in human serum. As such, the acceptance criteria and study design are focused on the analytical accuracy and precision of the diagnostic assay rather than a complex AI-driven medical device that uses machine learning to classify or detect.
Based on the provided text, here's a breakdown of the information requested, with "N/A" where the information is not applicable to this type of device or study:
Acceptance Criteria and Device Performance for Lucica® Glycated Albumin-L
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a "table of acceptance criteria" in the format one might expect for an AI/ML device (e.g., target specificity, sensitivity, etc.). Instead, it details various analytical performance studies with implicit criteria for acceptable performance (e.g., %CV limits for precision, linearity range, interference limits).
Here's a summary of the performance data, with implied acceptance criteria based on standard laboratory assay validation:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Single Site Repeatability: %CV ≤ 2.6% | Single Site Repeatability: Max %CV = 2.6% (for Pool serum 5) Single Site Within-Laboratory: Max %CV = 3.3% (for Pool serum 5) |
| Single Site Within-Laboratory: %CV ≤ 3.3% | ||
| Multisite Reproducibility: %CV ≤ 1.6% | Multisite Reproducibility: Max %CV = 1.6% (for Pool serum 1) | |
| Linearity | Linear across the range from lowest to highest GA value serum | Supported linearity across the range of 173 to 979 mmol/mol. |
| Traceability | Traceable to established reference materials | Traceable to "Committee on Diabetes Mellitus Indices of the Japan Society of Clinical Chemistry-recommended reference measurement procedure and reference materials for glycated albumin determination" and Secondary Calibrators (Glycated Albumin Certified Material, JCCRM 611-1, M, H, HH). |
| Stability | Reagent, Calibrator, Control stability within specified limits | Reagent Shelf-life: 12 months (2-8 °C). Open Reagent: 1 month (Modular P reagent cabinet). Calibrator Shelf-life: 12 months (≤ 8 °C). Calibrator In-use: 2 weeks (≤ 8 °C). Control Shelf-life: 12 months (≤ 8 °C). Control In-use: 1 month (≤ 8 °C). |
| Limit of Detection (LoD) | Defined and quantifiable | GA LoB: 6.9 µmol/L; GA LoD: 7.9 µmol/L; GA LoQ: 9.7 µmol/L. Albumin LoB: 3.8 µmol/L; Albumin LoD: 7.0 µmol/L; Albumin LoQ: 21.8 µmol/L. |
| Interference Studies | Bias due to interferents ≤ 10% | No significant interference (% bias ≤ 10%) for: - Unconjugated bilirubin (20.0 mg/dL) - Conjugated bilirubin (20.0 mg/dL) - Hemoglobin (288 mg/dL) - Glucose (1,000 mg/dL) - Ascorbic Acid (100 mg/dL) - Triglycerides (1,516 mg/dL) - Uric Acid (23.5 mg/dL) Noted interference: Hemoglobin at 384 mg/dL decreased GA by 12.9% (at 240 mmol/mol) and 9.9% (at 467 mmol/mol). Triglycerides at 2,004 mg/dL decreased GA by 11.6% (at 232 mmol/mol) and 2.6% (at 467 mmol/mol). |
| Reference Range | Established for healthy non-diabetic subjects | 183 and 259 mmol/mol for 262 healthy non-diabetic subjects in the US. |
2. Sample Size for Test Set and Data Provenance
-
Test Sample Size:
- Precision (Single Site): 5 serum sample pools, each assayed twice per run, two runs per day, for 20 testing days (N=80 results for each pool).
- Precision (Multisite): 3 serum sample pools, tested at 3 different laboratories. Each sample assayed five replicates per run, one run per day, for five testing days (N=25 results per site per pool, total 75 results per pool across sites).
- Linearity: Lowest and highest GA value serum sample pools mixed in varying ratios. Samples analyzed in triplicate in one run. (Specific number of mixed samples not detailed).
- LoB, LoD, LoQ: Performed according to CLSI Guideline EP17-A2. (Specific number of samples not detailed, but standard for these studies).
- Interference: Two base serums (Normal pool serum and DM serum) with potential interfering substances spiked in. Six total different concentration levels prepared. (Specific number of samples not detailed, but standard for these studies).
- Reference Range Study: 262 healthy non-diabetic subjects.
-
Data Provenance: The reference range study was conducted on subjects in the US. Other analytical performance studies (precision, linearity, etc.) are laboratory-based and do not specify patient origin beyond "serum samples" or "serum sample pools." The studies are retrospective in the sense that they are validations of an already developed assay, not prospective patient trials for clinical outcomes.
3. Number of Experts and Qualifications for Ground Truth
- N/A. For this type of in vitro diagnostic device (a quantitative assay), "ground truth" is established by reference methods or gravimetric/analytical standards (e.g., certified reference materials for traceability, known concentrations for linearity and spiked interference studies). There are no human experts classifying images or clinical findings that require consensus.
4. Adjudication Method for Test Set
- N/A. As mentioned above, this device performs a quantitative measurement, not a classification or diagnosis that would require expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- N/A. This is a laboratory-based quantitative assay, not an imaging device or an AI system that assists human readers. Therefore, an MRMC study is not applicable.
6. Standalone (Algorithm Only) Performance
- Yes. All the performance data (precision, linearity, LoD, interference, etc.) represent the standalone performance of the Lucica® Glycated Albumin-L assay itself, without human-in-the-loop assistance for interpretation. The device outputs a quantitative measurement of glycated albumin.
7. Type of Ground Truth Used
- The ground truth for the analytical performance studies (precision, linearity, LOQ/LOD, interference) is based on analytical standards, reference materials, known spiked concentrations, and statistical methods (e.g., CLSI guidelines).
- For the reference range study, the ground truth is established by the clinical status of the subjects (healthy non-diabetic), confirmed by their diagnostic status.
- The "Outcomes" section refers to peer-reviewed scientific literature demonstrating the clinical utility of glycated albumin as a biomarker for glycemic control and its association with micro/macrovascular complications. This is external evidence supporting the medical relevance of the analyte, not ground truth specific to this device's performance validation.
8. Sample Size for Training Set
- N/A. This is a quantitative chemical assay, not an AI/ML model that requires a "training set" in the computational sense. The reagents and assay parameters are developed and optimized through traditional chemistry and engineering processes.
9. How the Ground Truth for the Training Set was Established
- N/A. (See point 8). The "training" for such a device involves chemical formulation, assay development, and calibration, which rely on established laboratory practices, chemical principles, and reference materials.
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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.
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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 FructosamineTest Kit (K023763)(Predicate) | SubstantialEquivalence | |
|---|---|---|---|
| REAGENTKITIntended Use /Indications forUse | The Lucica® Glycated Albumin-L is intended to be used for thequantitative measurement ofglycated albumin in humanserum on compatible clinicalchemistry analyzers. Themeasurement of glycatedalbumin is useful for theintermediate term (preceding 2-3weeks) monitoring of glycemiccontrol in patients with diabetes.For in vitro diagnostic use only. | The Randox LaboratoriesLimited Fructosamine test kitis an in vitro diagnosticenzymatic assay for thequantitative determination ofglycated protein(fructosamine) in humanserum or plasma.Measurement of glycatedserum protein isrepresentative of the meanblood glucose levels over thepreceding 2-3 weeks.For in vitro diagnostic useonly. | 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
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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 significantinterference | |
|---|---|---|
| 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:
-
- Nathan DM, McGee P, Steffes MW, et al. Diabetes. 2014; 63(1): 282-290
-
- Selvin E et al., Lancet Diabetes Endocrinol. 2014; 2(4): 279-88
-
- Pan J et al. J Diabetes Complic. 2014; 772-778.
-
- 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.
-
- Yang ZK, et al. Int J Cardiol. 2015 Oct 15; 197: 241-7.
§ 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).