Medconn Glycated Hemoglobin Test system
Device Facts
| Record ID | K242911 |
|---|---|
| Device Name | Medconn Glycated Hemoglobin Test system |
| Applicant | Shanghai Medconn Medical Technology Co., Ltd. |
| Product Code | PDJ · Clinical Chemistry |
| Decision Date | Jun 20, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1373 |
| Device Class | Class 2 |
Intended Use
Medconn Glycated Hemoglobin Test System is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood or hemolysate with ion-exchange high performance liquid chromatography (HPLC) using the Medconn HbA1c Assay Kit (HPLC) on the Medconn Glycated Hemoglobin Analyzer, models MQ3000 and MQ3000PT. Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
Device Story
Medconn Glycated Hemoglobin Test System (models MQ3000/MQ3000PT) uses ion-exchange HPLC to quantify HbA1c in K2-EDTA venous whole blood or hemolysate. System includes analyzer, HbA1c Assay Kit (reagents A-D), calibrators, controls, and column kit. Analyzer performs automated hemolysis/dilution for whole blood or accepts pre-diluted samples. High-pressure pump delivers buffer gradient to analytical cartridge; hemoglobin species separate via ionic interactions. Detector measures absorbance at 415nm; software records digital chromatograms, identifies peaks, and calculates HbA1c concentration (NGSP % and IFCC mmol/mol). Used in clinical settings by trained personnel. Output provides clinicians with quantitative HbA1c values to support diabetes diagnosis and long-term glycemic monitoring.
Clinical Evidence
Bench testing only. Precision studies (n=720 measurements per sample) showed total CVs <2.1%. Linearity confirmed across 3.0-15.0% HbA1c range (R² ≥ 0.9998). Interference testing confirmed no significant impact from endogenous substances, common drugs, or hemoglobin variants (HbS, HbC, HbD, HbE, HbA2, HbF). Method comparison against predicate (n=124 samples) demonstrated strong agreement (Deming slope 1.0074 for whole blood; 0.9894 for hemolysate).
Technological Characteristics
Ion-exchange high-performance liquid chromatography (HPLC). Analyzes hemoglobin species via buffer gradient and analytical cartridge. Absorbance measured at 415nm. Sample types: K2-EDTA whole blood. Connectivity: Standalone analyzer. Software performs peak identification and quantification. Standardized to IFCC reference calibrators.
Indications for Use
Indicated for quantitative determination of HbA1c in human whole blood or hemolysate to aid in diabetes diagnosis, identify patients at risk for diabetes, and monitor long-term blood glucose control in individuals with diabetes mellitus.
Regulatory Classification
Identification
A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.
Special Controls
(b) Classification. Class II (special controls). Hemoglobin A1c test systems must comply with the following special controls: 1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA. 2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity and interference, including the following: i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0%, 6.5%, 8.0% and 12% hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least 3 lots of the device and 3 instruments, as applicable. ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the new device and compare results of the new device to results of the standardized test method. Results must demonstrate little or no bias versus the standardized method. iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6%. iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2 and Hemoglobin S. 3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.
*Classification.* Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA. (2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following: (i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable. (ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method. (iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent. (iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S. (3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.
Predicate Devices
- D-100™ HbA1c (K151321)
Related Devices
- K252749 — Medconn 8K Glycated Hemoglobin Test System · Shanghai Medconn Medical Technology Co., Ltd. · Jan 6, 2026
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K242911
B Applicant
Shanghai Medconn Medical Technology Co., Ltd.
C Proprietary and Established Names
Medconn Glycated Hemoglobin Test system
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PDJ | Class II | 21 CFR 862.1373 - Hemoglobin A1c Test System | CH - Clinical Chemistry |
| LCP | Class II | 21 CFR 864.7470 - Glycosylated hemoglobin assay | HE - Hematology |
## II Submission/Device Overview:
A Purpose for Submission:
New device
B Measurand:
Whole Blood Glycosylated Hemoglobin (HbA1c)
C Type of Test:
Quantitative Ion exchange High Performance Liquid Chromatography (HPLC)
## III Intended Use/Indications for Use:
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K242911 - Page 2 of 14
## A Intended Use(s):
See Indications for Use below.
## B Indication(s) for Use:
Medconn Glycated Hemoglobin Test System is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood or hemolysate with ion-exchange high performance liquid chromatography (HPLC) using the Medconn HbA1c Assay Kit (HPLC) on the Medconn Glycated Hemoglobin Analyzer, models MQ3000 and MQ3000PT. Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
- The device should not be used in newborns, pregnant patients, patients with heterozygous sickle cell trait, hemolytic diseases and recent significant or chronic blood loss.
- The device should not be used in patients during pregnancy for diagnosis of gestational diabetes.
- Samples of patients with hemolytic anemia may present a decreased value of HbA1c due to a shortened life span of their red blood cells. The magnitude of this effect depends on the severity of the anemia.
- In cases of rapidly evolving type 1 diabetes the increase of HbA1c values might be delayed compared to the acute increase in glucose concentrations. In these conditions diabetes mellitus must be diagnosed based on plasma glucose concentration and/or the typical clinical symptoms.
- The device should not be used to diagnose or monitor patients with conditions that alter the life span of the red blood cells, such as: iron deficiency and hemolytic anemia, various hemoglobinopathies, thalassemia, hereditary spherocytosis, malignancies and severe chronic hepatic and renal disease.
## D Special Instrument Requirements:
The Medconn Glycated Hemoglobin Analyzer
## IV Device/System Characteristics:
### A Device Description:
The Medconn Glycated Hemoglobin Test System consists of the following components:
- The Medconn Glycated Hemoglobin Analyzer; models MQ3000 and MQ3000PT: automated instrument for running the Medconn HbA1c Assay (HPLC) to measure the content of HbA1c in human whole blood. These analyzers are identical except the sample
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disc cover colors. The color for model MQ3000 analyzer is blue, and the color for the MQ3000PT is black.
- The Medconn HbA1c Assay Kit (HPLC): distributed with 200-test packages, 400-test packages, and 800-test packages that contains HbA1c reagents A, B, C, D. These reagents are succinate buffers with different ionic strengths used for elution of different substances in HPLC.
- The Medconn Hemoglobin A1c Calibrator: lyophilized powers containing hemoglobin, 1 vial of Calibrator Level 1 (20 uL), and 1 vial of Calibrator Level 2 (20 uL). Each Calibrator Pack contains calibrator values which have been value assigned using calibrators that are traceable to the internationally-agreed IFCC calibrator (HBA-IFCC-cal).
- The Medconn Hemoglobin A1c Control (2 levels): lyophilized powders containing hemoglobin, which are reconstituted with labeled volume of distilled water or are directly reconstituted into diluted samples using haemolyser.
- The Medconn HbA1c Haemolyser (reagent H): used for pretreatment of blood for HbA1c testing, containing deionized water, a surfactant, and less than 0.05% of sodium azide as a preservative.
- The Medconn HbA1c Column Kit (HPLC): assembled HPLC columns filled with hydrophilic polymer for use with the Medconn MQ3000 and MQ3000PT Glycated Hemoglobin analyzers.
## B Principle of Operation:
The device is based on the principle of chromatographic separation of HbA1c in high performance liquid chromatography (HPLC). A high-pressure pumping system delivers a buffer solution to an analytical cartridge and detector. The analyzer has two modes: whole blood mode and manually hemolyzed and pre-diluted sample mode. Whole blood samples undergo an automatic hemolysis and dilution process before being introduced into the analytical flow path. The manually hemolyzed and pre-diluted samples loaded in sample cups at designated location are directly introduced for analysis.
A programmed buffer gradient of increasing ionic strength delivers the sample to the analytical cartridge where the hemoglobin species are separated based upon their ionic interactions with the cartridge material and the buffer gradient. The separated hemoglobin species then pass through the flow cell where changes in the absorbance are measured at 415nm and recorded as a digital chromatogram.
The software performs an analysis of the hemoglobin peaks in the chromatogram, recording information including retention time, peak area, and relative peak area of the detected substance over the total peak area of all substances. Peaks identified as target analytes are calibrated to generate a report, a chromatogram and the HbA1c concentration in % and mmol/L units for each sample.
## C Instrument Description Information:
1. Instrument Name:
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The Medconn Glycated Hemoglobin Analyzer; models MQ3000 and MQ3000PT
2. Specimen Identification:
Sample identification is via barcoding or manual entry.
3. Specimen Sampling and Handling:
Venous whole blood samples collected in K₂-EDTA can be stored at 2-8°C for 5 days and at -20°C for 30 days.
Hemolysate should be stored at 2-8°C for less than 8 hours.
4. Calibration:
Calibration should be performed once following the use of a new batch of the Medconn HbA1c assay kit, or the installation of a new chromatographic column, or the instrument repair, maintenance, or replacement of key components. Additional calibration may be performed at the discretion of the laboratory. Calibration is performed using the Medconn Hemoglobin A1c Calibrators.
5. Quality Control:
Quality control of the Medconn Glycated Hemoglobin test system can be conducted using the Medconn Hemoglobin A1c Controls. Labeling for the device states that in keeping with good laboratory practice, at least one diabetic and one non-diabetic control specimen should be tested each day patient samples are tested. Each laboratory should establish its own guidelines for corrective action to be taken if the expected control values are not obtained.
V Substantial Equivalence Information:
A Predicate Device Name(s):
D-100 HbA1c, D-100 HbA1c Calibrator Pack
B Predicate 510(k) Number(s):
K151321
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K242911 | K151321 |
| --- | --- | --- |
| Device Trade Name | Medconn Glycated Hemoglobin Test System | D-100 HbA1c |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Intended for the quantitative determination of hemoglobin A1c in human whole blood as an aid in | Same |
K242911 - Page 4 of 14
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| Device & Predicate Device(s): | K242911 | K151321 |
| --- | --- | --- |
| | diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. | |
| Test principle | Ion exchange HPLC | Same |
| Sample Types | Human whole blood, hemolysate | Same |
| Standardization/ Traceability | Traceable to the Diabetes Control and Complications Trial (DCCT) reference method and IFCC. Certified via the National Glycohemoglobin Standardization Program (NGSP). | Same |
| General Device Characteristic Differences | | |
| Matrices | K2-EDTA | K2-EDTA, K3-EDTA Potassium Oxalate/ Sodium Fluoride, Sodium Citrate, Sodium Heparin, Lithium Heparin |
| Measuring range | 3.0% to 15.0% (NGSP)
9 to 195 mmol/mol HbA1c (IFCC) | 3.5 to 20% (NSGP)
15 to 195 mmol/mol HbA1c (IFCC) |
VI Standards/Guidance Documents Referenced:
- CLSI EP05-A3 (Reaffirmed: September 2019): Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
- CLSI EP06 2nd Edition: Evaluation of the Linearity of Quantitative Measurement Procedures
- CLSI EP07 3rd Edition: Interference Testing in Clinical Chemistry
- CLSI EP09c 3rd Edition: Measurement Procedure Comparison and Bias Estimation Using Patient Samples
- CLSI EP25-A (Replaces EP25-P): Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline
- IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)]
- IEC 61326-1 Edition 3.0 2020-10: Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
- IEC 61326-2-6 Edition 3.0 2020-10: Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
K242911 - Page 5 of 14
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- IEC 81001-5-1 Edition 1.0 2021-12: Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
- AAMI TIR69:2017/(R2020): Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems
- IEEE ANSI USEMCSC C63.27-2021: American National Standard for Evaluation of Wireless Coexistence
- ISO 17511 Second edition 2020-04: In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
## VII Performance Characteristics (if/when applicable):
## A Analytical Performance:
Since both models of analyzer are functionally identical and only differ in sample disc colors, model MQ3000 was used as the representative model for the studies described below to support both analyzer models.
## 1. Precision/Reproducibility:
Precision studies were conducted with the Medconn Glycated Hemoglobin Test System using four K2 EDTA venous whole blood samples at concentrations near 5%, 6.5%, 8%, and 12% HbA1c (S1, S2, S3, and S4 respectively) and two quality control samples at concentrations near 6% and 11% HbA1c (QC1 and QC2 respectively). Samples were analyzed on three Medconn Glycated Hemoglobin Analyzer instruments with three lots of reagents in duplicate per run, two runs per day, for 20 days. For each sample there were 720 measurements. Results are shown in the tables below.
Venous whole blood, all Analyzers Combined, % HbA1c (NGSP) units
| Sample | Mean Values (%) | %CV, Percent CV for All Analyzers Combined | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Repeatability | Between-Run | Between-Day | Between-Lot | Between-Analyzer | Total |
| S1 | 5.11 | 1.27 | 0.74 | 0.56 | 0.21 | 0.08 | 1.59 |
| S2 | 6.60 | 1.15 | 0.26 | 0.21 | 0.33 | 0.02 | 1.24 |
| S3 | 8.05 | 1.05 | 0.64 | 0.21 | 0.22 | 0.10 | 1.27 |
| S4 | 12.25 | 0.71 | 0.39 | 0.26 | 0.08 | 0.05 | 0.86 |
| QC1 | 5.71 | 1.19 | 0.39 | 0.54 | 0.00 | 0.11 | 1.36 |
| QC2 | 11.66 | 0.85 | 0.23 | 0.20 | 0.13 | 0.00 | 0.91 |
Venous whole blood, all Analyzers Combined, mmol/mol (IFCC) units
| Sample | Mean Values mmol/mol | %CV, Percent CV for All Analyzers Combined | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Repeatability | Between-Run | Between-Day | Between-Lot | Between-Analyzer | Total |
| S1 | 32.27 | 1.65 | 1.03 | 0.61 | 0.39 | 0.14 | 2.08 |
| S2 | 48.64 | 1.72 | 0.26 | 0.43 | 0.51 | 0.11 | 1.86 |
| S3 | 64.42 | 1.42 | 0.77 | 0.31 | 0.25 | 0.18 | 1.68 |
| S4 | 110.41 | 0.81 | 0.43 | 0.30 | 0.09 | 0.05 | 0.97 |
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QC1 38.85 1.76 0.41 0.72 0.03 0.18 1.95
QC2 103.92 1.09 0.23 0.24 0.15 0* 1.14
* Negative variance component values have been sent to zero
Hemolysate, all Analyzers Combined, % HbA1c (NGSP) units
| Sample | Mean Values (%) | %CV, Percent CV for All Analyzers Combined | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Repeatability | Between-Run | Between-Day | Between-Lot | Between-Analyzer | Total |
| S1 | 5.20 | 1.13 | 0.62 | 0.58 | 0.18 | 0.06 | 1.43 |
| S2 | 6.41 | 1.06 | 0.51 | 0.07 | 0.19 | 0.13 | 1.20 |
| S3 | 7.89 | 0.85 | 0.48 | 0.22 | 0.13 | 0.05 | 1.01 |
| S4 | 12.15 | 0.75 | 0.39 | 0.14 | 0.16 | 0.07 | 0.87 |
| QC1 | 5.70 | 1.08 | 0.72 | 0.38 | 0.16 | 0.04 | 1.36 |
| QC2 | 11.54 | 0.84 | 0.28 | 0.22 | 0.11 | 0.02 | 0.92 |
Hemolysate, all Analyzers Combined, mmol/mol (IFCC) units
| Sample | Mean Values mmol/mol | %CV, Percent CV for All Analyzers Combined | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Repeatability | Between-Run | Between-Day | Between-Lot | Between-Analyzer | Total |
| S1 | 33.27 | 0.73 | 1.29 | 0.99 | 0.22 | 0.09 | 1.80 |
| S2 | 46.51 | 1.47 | 0.70 | 0* | 0.25 | 0.16 | 1.63 |
| S3 | 62.76 | 1.22 | 0.69 | 0.20 | 0.22 | 0 | 1.43 |
| S4 | 109.3 | 0.93 | 0.48 | 0.19 | 0.18 | 0.10 | 1.08 |
| QC1 | 38.79 | 1.69 | 1.13 | 0.33 | 0.26 | 0.14 | 2.08 |
| QC2 | 102.67 | 1.06 | 0.33 | 0.28 | 0.11 | 0.06 | 1.15 |
2. Linearity:
Linearity was evaluated for the Medconn Glycated Hemoglobin Test system with three lots of reagents using a dilution series consisting of 11 levels of HbA1c prepared by mixing high and low whole blood pools in K2 EDTA. The expected sample concentrations were 3.00%, 4.21%, 5.42%, 6.63%, 7.84%, 9.05%, 10.26%, 11.47%, 12.68%, 13.89%, and 15.10% HbA1c. The samples were either analyzed as whole blood samples or were manually hemolyzed before analyzing. Three replicates were tested at each concentration. The measured mean values were compared to the expected values. The linear regressions for the three lots of reagents are the following:
Venous whole blood, NGSP unit:
1st lot of reagent: Y=0.9922X + 0.0687, R²=0.9999
2nd lot of reagent: Y=0.9980X + 0.0287, R²=0.9998
3rd lot of reagent: Y=1.0015X - 0.0181, R²=0.9999
Venous whole blood, IFCC unit:
1st lot of reagent: Y=0.9927X + 0.5509, R²=0.9999
2nd lot of reagent: Y=0.9983X + 0.2132, R²=0.9999
3rd lot of reagent: Y=1.0019X - 0.2590, R²=0.9999
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## Hemolysate, NGSP unit:
1st lot of reagent: Y=0.9990X + 0.0227, R²=0.9998
2nd lot of reagent: Y=0.9980X + 0.0287, R²=0.9998
3rd lot of reagent: Y=0.9940X + 0.0559, R²=0.9999
## Hemolysate, IFCC unit:
1st lot of reagent: Y=0.9985X + 0.2955, R²=0.9998
2nd lot of reagent: Y=0.9989X + 0.2219, R²=0.9998
3rd lot of reagent: Y=0.9943X + 0.4784, R²=1.0000
Results of the linearity study support the claimed measuring range of the device of 3.0% to 15% HbA1c (15-195 mmol/mol).
## 3. Analytical Specificity/Interference:
### Endogenous Substances:
Interference studies were performed to assess the impact of endogenous substances on the performance of the Medconn Glycated Hemoglobin Test System. Pooled whole blood at two HbA1c levels (~6.5 and ~8.0% HbA1c) in K2 EDTA spiked with potential interferent was analyzed in replicates of two and compared to the same whole blood pool without interferent (control). The highest concentrations at which no significant interference (a difference of no more than ±7% from the control sample as defined by the sponsor) was observed are summarized below:
| Interferent | Highest Concentration Level Tested with No Significant Interference (mg/dL) |
| --- | --- |
| Unconjugated Bilirubin | 21.3 |
| Conjugated Bilirubin | 19.2 |
| Rheumatoid Factors | 750 IU/mL |
| Total Protein | 21g/dL |
| Triglycerides | 6000 |
| Glucose | 2000 |
### Exogenous Substances:
Interference studies were performed to assess the impact of exogenous substances on the performance of the Medconn Glycated Hemoglobin Test System. Pooled whole blood at two HbA1c levels (~6.5 and ~8.0% HbA1c) in K2 EDTA spiked with potential interferent was analyzed and compared to the same whole blood pool without interferent (control). The highest concentrations at which no significant interference (a difference of no more than ±7% from the control sample as defined by the sponsor) was observed are summarized below:
| Interferent | Highest Concentration Level Tested with No Significant Interference (mg/dL) |
| --- | --- |
| Acetaminophen | 200 |
| Acetylcysteine | 166 |
| Ampicillin-Na | 1000 |
| Ascorbic acid | 100 |
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K242911 - Page 9 of 14
| Cefoxitin | 2500 |
| --- | --- |
| Cyclosporine | 5 |
| Doxycyclin | 50 |
| Heparin | 5000 U/L |
| Ibuprofen | 500 |
| Levodopa | 20 |
| Methyldopa | 20 |
| Metronidazole | 200 |
| Phenylbutazone | 400 |
| Rifampicin | 64 |
| Theophylline | 100 |
## Cross Reactivity with Hemoglobin Derivatives:
Potential interference from Labile HbA1c, Carbamylated Hb, Acetylated Hb were evaluated. Two HbA1c concentrations of pooled whole blood (~6.5 and ~8.0% HbA1c) were spiked with the prepared potential interferent. The %HbA1c values were compared to the same control sample with no potential interferent present. Significant interference was defined by the sponsor as ≥7% change in HbA1c value of the mean of the test samples relative to the mean of the control samples. The test results and conclusions are as follows:
- Labile A1c - (up to 2000 mg/dL glucose) does not interfere with this assay.
- Carbamylated Hb - (up to 10 mg/dL Potassium cyanate) does not interfere with this assay.
- Acetylated Hb - (up to 500 mg/dL acetylsalicylic acid) does not interfere with this assay.
Results showed there was no cross reactivity with these hemoglobin derivatives at tested levels and the labeling states that at physiologically occurring concentrations there is no interference from labile A1c, carbamylated hemoglobin or acetylated hemoglobin.
## Hemoglobin Variant Interference:
Two hemoglobin variant studies were performed using K2 EDTA venous whole blood samples known to contain hemoglobin variants HbS, HbC, HbD, HbE, HbA2, and HbF. The samples containing the hemoglobin variants were tested using the Medconn Glycated Hemoglobin Test system and using comparator methods that have been demonstrated to be free from interference by these hemoglobin variants. The following table summarizes the tested samples:
### Hemoglobin Variant Samples Tested in Study #1
| Hemoglobin Variant | Number of Samples | Variant Concentration Range (%) | Range of HbA1c Concentration (%) |
| --- | --- | --- | --- |
| HbS | 11 | 30 – 42 | 5.1 – 11.4 |
| HbC | 10 | 30 – 40 | 5.0 – 10.9 |
| HbD | 13 | 23 – 41 | 5.4 – 10.1 |
| HbE | 12 | 21 – 30 | 5.5 – 11.6 |
| HbA2 | 10 | 4.8 – 6.2 | 5.1 – 11.7 |
| HbF | 11 | 4.3 – 33 | 4.6 – 12.6 |
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Hemoglobin Variant Samples Tested in Study #2
| Hemoglobin Variant | Number of Samples | Variant Concentration Range (%) | Range of HbA1c Concentration (%) |
| --- | --- | --- | --- |
| HbS | 25 | 36 – 42 | 5.0 – 14.0 |
| HbC | 25 | 30 – 38 | 5.0 – 10.9 |
| HbD | 25 | 39 – 43 | 5.3 – 14.7 |
| HbE | 25 | 23 – 27 | 5.1 – 12.2 |
| HbA2 | 20 | 3.5 – 5.6 | 5.2 – 9.0 |
| HbF | 23 | 3.0 – 27 | 5.5 – 16.5 |
Summary of Hemoglobin Variant Test Results for Study #1
| Hemoglobin Variant | %Bias, Percent Relative Bias Observed Relative to the Comparator Method | | | |
| --- | --- | --- | --- | --- |
| | ~ 6.5 % HbA1c | | ~ 8.0% HbA1c | |
| | %Bias | Range of %Bias | %Bias | Range of %Bias |
| HbS | -1.34 | -3.54 to 1.98 | -1.45 | -3.97 to 1.48 |
| HbC | -0.96 | -2.65 to 1.65 | -1.31 | -3.43 to 0.00 |
| HbD | -0.10 | -1.65 to 1.65 | -1.17 | -3.08 to 1.52 |
| HbE | -0.86 | -1.83 to 0.88 | -0.91 | -2.12 to 1.48 |
| HbA2 | -0.29 | -1.71 to 1.90 | -1.09 | -2.82 to 2.04 |
| HbF | -0.23 | -1.98 to 2.20 | -0.16 | -1.99 to 3.01 |
Summary of Hemoglobin Variant Test Results for Study #2
| Hemoglobin Variant | %Bias, Percent Relative Bias Observed Relative to the Comparator Method | | | |
| --- | --- | --- | --- | --- |
| | ~ 6.5 % HbA1c | | ~ 8.0% HbA1c | |
| | %Bias | Range of %Bias | %Bias | Range of %Bias |
| HbS | 1.20 | -1.59 to 3.23 | -0.31 | -2.35 to 1.18 |
| HbC | 1.59 | 0.00 to 3.23 | 0.27 | -1.20 to 1.33 |
| HbD | 0.93 | -1.67 to 3.28 | 0.67 | 0.00 to 1.33 |
| HbE | 0.14 | -0.98 to 0.93 | -0.02 | -1.16 to 1.38 |
| HbA2 | 1.01 | 0.00 to 3.03 | -0.66 | -2.53 to 2.41 |
| HbF | 0.59 | -1.67 to 3.08 | 0.16 | -2.38 to 2.50 |
Significant interference was defined as $\geq 7\%$ change in HbA1c values in the presence of the hemoglobin variants relative to the control. The results show that there is no significant interference for HbS, HbC, HbE, HbD, HbA2, and HbF at the concentrations stated in the table above.
4. Assay Reportable Range:
The reportable range for this device is $3.0\% \sim 15.0\% \%$ HbA1c.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
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Traceability:
The Medconn Glycated Hemoglobin Test System is traceable to the International Federation of Clinical Chemistry (IFCC) reference calibrators. The assay is certified by the National Glycohemoglobin Standardization Program (NGSP) and IFCC. The NGSP and IFCC certification expires in one year. See the NGSP website for current certification at http://www.ngsp.org. HbA1c results are provided to users in two different units: NGSP equivalent units (%) and IFCC equivalent units (mmol/mol). These two units are converted using the Master Equation: NGSP (%) = 0.09148 x IFCC (mmol/mol) + 2.152.
6. Detection Limit:
Not applicable.
7. Assay Cut-Off:
Not applicable.
8. Accuracy (Instrument):
See method comparison study below.
9. Carry-Over:
A Carryover study was performed to determine whether the Medconn Glycated Hemoglobin Test System demonstrated that HbA1c results were not impacted by various sequences of running low and high HbA1c containing samples.
B Comparison Studies:
1. Method Comparison with the Predicate Device:
Method comparison study was performed to compare the candidate device results with those from the predicate device (i.e., Bio-Rad D-100 HbA1c Test) performed at a NGSP secondary reference laboratory. The study was conducted with both the venous whole blood and hemolysate of the Medconn Glycated Hemoglobin analyzer. The distribution of samples spanning the measuring interval is as follows:
| HbA1c levels, % | # of samples tested | % of sample tested |
| --- | --- | --- |
| ≤ 5 | 6 | 4.84 |
| 5.0 – 6.0 | 15 | 12.10 |
| 6.0 – 6.5 | 31 | 25.00 |
| 6.5 – 7.0 | 30 | 24.19 |
| 7.0 – 8.0 | 18 | 14.52 |
| 8.0 – 9.0 | 10 | 8.06 |
| > 9.0 | 14 | 11.29 |
| Total | 124 | 100 |
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Regression analyses were performed for the candidate device versus the comparator method. Summary of results are as follows:
Regression results for venous whole blood, NGSP unit:
| Method | Slope | 95% CI | y-intercept | 95% CI |
| --- | --- | --- | --- | --- |
| Deming | 1.0074 | 0.9990 - 1.0158 | 0.0004 | -0.0609- 0.0617 |
| Passing-Bablok | 1.0000 | 1.0000 - 1.0154 | 0.0500 | -0.0667 - 0.0500 |
Regression results for hemolysate, NGSP unit:
| Method | Slope | 95% CI | y-intercept | 95% CI |
| --- | --- | --- | --- | --- |
| Deming | 0.9894 | 0.9781 – 1.0007 | 0.1940 | 0.1139 - 0.2740 |
| Passing-Bablok | 1.0000 | 1.0000 - 1.0000 | 0.1000 | 0.1000 - 0.1000 |
Bias Estimation for venous whole blood:
| HbA1c levels (%) | Deming | | Passing Boblok | |
| --- | --- | --- | --- | --- |
| | Bias (%) | %Bias | Bias (%) | %Bias |
| 5.0 | 0.0374 | 0.7480 | 0.0500 | 1.0000 |
| 6.5 | 0.0485 | 0.7462 | 0.0500 | 0.7692 |
| 8.0 | 0.0596 | 0.7450 | 0.0500 | 0.6250 |
| 12.0 | 0.0892 | 0.7433 | 0.0500 | 0.4167 |
Bias Estimation for hemolysate:
| HbA1c levels (%) | Deming | | Passing Boblok | |
| --- | --- | --- | --- | --- |
| | Bias (%) | %Bias | Bias (%) | %Bias |
| 5.0 | 0.1410 | 2.8200 | 0.1000 | 2.0000 |
| 6.5 | 0.1251 | 1.9246 | 0.1000 | 1.5385 |
| 8.0 | 0.1092 | 1.3650 | 0.1000 | 1.2500 |
| 12.0 | 0.0668 | 0.5567 | 0.1000 | 0.8333 |
## Total Error calculations and estimation:
The bias estimation values determined in the method comparison study and the precision estimates determined in the precision study were used to determine the total error at each of the HbA1c levels listed in the tables below. Total error was calculated by the following equation:
$$
\% \mathrm{TE} = \left| \% \mathrm{Bias} \right| + (1.96 \times \% \mathrm{CV}) \times (1 + \% \mathrm{Bias} / 100)
$$
Total Error for venous whole blood:
| Regression | HbA1c levels, % | %Bias | %CV | %TE |
| --- | --- | --- | --- | --- |
| Deming | 5.0 | 0.75 | 1.59 | 3.89 |
| | 6.5 | 0.75 | 1.24 | 3.20 |
| | 8.0 | 0.75 | 1.27 | 3.26 |
| | 12.0 | 0.74 | 0.86 | 2.44 |
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| Regression | HbA1c levels, % | %Bias | %CV | %TE |
| --- | --- | --- | --- | --- |
| Passing Boblok | 5.0 | 1.00 | 1.59 | 4.15 |
| | 6.5 | 0.77 | 1.24 | 3.22 |
| | 8.0 | 0.63 | 1.27 | 3.13 |
| | 12.0 | 0.42 | 0.86 | 2.11 |
**Total Error for hemolysate:**
| Regression | HbA1c levels, % | %Bias | %CV | %TE |
| --- | --- | --- | --- | --- |
| Deming | 5.0 | 2.82 | 1.43 | 5.70 |
| | 6.5 | 1.92 | 1.2 | 4.32 |
| | 8.0 | 1.37 | 1.01 | 3.37 |
| | 12.0 | 0.56 | 0.87 | 2.27 |
| Passing Boblok | 5.0 | 2.00 | 1.43 | 4.86 |
| | 6.5 | 1.54 | 1.2 | 3.93 |
| | 8.0 | 1.25 | 1.01 | 3.25 |
| | 12.0 | 0.83 | 0.87 | 2.55 |
2. **Matrix Comparison:**
Not applicable.
**C Clinical Studies:**
1. **Clinical Sensitivity:**
Not applicable.
2. **Clinical Specificity:**
Not applicable.
3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):**
Not applicable.
**D Clinical Cut-Off:**
Not applicable.
**E Expected Values/Reference Range:**
The sponsor provided the following expected values in their labeling:
The following HbA1c ranges recommended by the American Diabetes Association (ADA) may be used as an aid in the diagnosis of diabetes mellitus$^{1-3}$.
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| Hemoglobin A1c | | Suggested Diagnosis |
| --- | --- | --- |
| NGSP % | IFCC mmol/mol | |
| ≥6.5 | ≥48 | Diabetic |
| 5.7–6.4 | 39–47 | Pre-Diabetic |
| <5.7 | <39 | Non-Diabetic |
$^{1}$ American Diabetes Association. Standards of Medical Care in Diabetes - 2013. Diabetes Care 2013 ; 36 (Suppl.1), S11-66.
$^{2}$ World Health Organization. Abbreviated Report of a WHO Consultation: WHO; 2011. Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus.
$^{3}$ American Diabetes Association. Standards of Medical Care for Patients with Diabetes Mellitus. Diabetes Care 2002 ; 25 (Suppl.1), S33-49.
## F Other Supportive Instrument Performance Characteristics Data:
See “Performance Characteristics” Section above
## VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
## IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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