(253 days)
Not Found
No
The device description and performance studies focus on enzymatic reactions and standard analytical methods, with no mention of AI or ML.
No.
This device is an in vitro diagnostic (IVD) assay used to measure 1,5-anhydroglucitol (1,5-AG) in serum or plasma for monitoring glycemic control in people with diabetes. It provides diagnostic information and is not intended to treat, cure, mitigate, or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only." This indicates its purpose is to aid in the diagnosis and monitoring of a medical condition.
No
The device description clearly outlines a chemical assay using enzymes and colorimetry to measure 1,5-AG in serum or plasma. This involves physical reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "For in vitro diagnostic use only." and describes its use for quantitative determination of 1,5-AG in serum or plasma for monitoring glycemic control in people with diabetes. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: Describes an enzymatic method for analyzing a biological sample (serum or plasma).
- Intended User/Care Setting: States "For professional use," indicating it's used in a clinical or laboratory setting for diagnostic purposes.
- Comparison Studies: Mentions comparison to a "predicate legally marketed 1,5- AG device," which is a common requirement for regulatory clearance of IVDs.
- Performance Studies: Details various performance studies (Precision, Linearity, LoB/LoD/LoQ, Analytical specificity, Comparison Studies, Reference Range Study) which are typical evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device(s): Lists a predicate device with a K number (K031604), which is a regulatory identifier for medical devices, further confirming its classification as a medical device, specifically an IVD given the context.
N/A
Intended Use / Indications for Use
Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only.
Product codes
NOZ
Device Description
Diazyme's 1.5-AG assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphoralated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate.
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
Not Found
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
Precision Study:
In the study, six serum samples were tested following CLSI EP5-A2 protocol.
Sample size: N=240 per sample type (6 types).
Linearity/Reportable Range:
Study design based on CLSI protocol EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures.
LoB/LoD/LoQ:
Determined according to CLSI EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline using three lots of the reagents on Beckman AU680.
Analytical specificity:
Diazyme 1,5-AG Assay was used to test low (5.0 µg/mL), medium (23.0 µg/mL), and high (50 ug/mL) 1,5-AG samples with various concentrations of substances following CLSI EP7-A2. Substances tested include Free Bilirubin, Bilirubin Conjugated, Hemoglobin, Ascorbic Acid, Triglyceride, Glucose, Maltose, Uric Acid, Creatinine, Urea.
Comparison Studies:
Protocol: Clinical and Laboratory Standards Institute EP9-A2 - Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline-Second Edition (2002).
For method comparison, the 1,5- AG Assay was evaluated by testing individual serum samples with comparison to predicate legally marketed 1,5- AG device.
Sample size: A total of 102 patient samples covering the AMR were tested by both 1,5- AG Assay and Predicate 1,5- AG Assay.
Reference Range Study:
To determine the reference interval of the normal population, serum samples from 140 apparently healthy males and 140 apparently healthy females were tested using the 1,5- AG Assay according to CLSI C28-A3 guideline.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Study:
Study type: Precision.
Sample size: Six serum samples, each tested for N=240 (implied total 1440 measurements).
Key results:
S1: Mean 3.07 µg/mL, Total CV% 4.8%
S2: Mean 5.70 µg/mL, Total CV% 2.2%
S3: Mean 11.56 µg/mL, Total CV% 1.3%
S4: Mean 23.17 µg/mL, Total CV% 0.9%
S5: Mean 61.84 µg/mL, Total CV% 1.0%
S6: Mean 97.26 µg/mL, Total CV% 1.0%
Linearity/Reportable Range:
Study type: Linearity.
Key results: The Diazyme 1,5-AG Assay is linear up to 116.7 µg/mL, and also in the clinically relevant range of 0.6- 10.0 µg/mL 1.5-AG.
LoB/LoD/LoQ:
Study type: Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ) determination.
Key results: The LOB was determined to be 0.3 µg/mL; the LOD was determined to be 0.5 µg/mL; the LOQ was determined to be 0.6 µg/mL.
Analytical specificity:
Study type: Analytical specificity / Interference study.
Key results: Substances normally present in the samples produced less than 10% deviation when tested at specified concentration levels.
Comparison Studies:
Study type: Method Comparison.
Sample size: 102 patient samples.
Key results:
Slope: 1.0164 (95% CI: 1.012 to 1.021)
Intercept: -0.21 (95% CI: -0.35 to -0.07)
Standard Error of Estimate: 0.51
Correlation Coefficient(R): 0.9997
R2: 0.9995
Reference Range Study:
Study type: Reference Interval determination.
Sample size: 140 apparently healthy males and 140 apparently healthy females.
Key results:
Reference interval for males: 8.19 to 32.19 µg/mL
Reference interval for females: 6.00 to 29.10 µg/mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GlycoMarkTM 1,5-anhydroglucitol (1,5-AG) (K031604)
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 4, 2018
Diazyme Laboratories Inc. Abhijit Datta VP of Operations 12889 Gregg Court Poway, CA 92130
Re: K180209
Trade/Device Name: Diazyme 1.5-AG Assay Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: NOZ Dated: August 23, 2018 Received: August 24, 2018
Dear Abhijit Datta:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K180209
Device Name Diazyme 1,5-AG Assay
Indications for Use (Describe)
Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance
with the requirements of SMDA 1990 and 21 CFR 807.92 The assigned 510(k) number K180209.
| Submitter's name: | Diazyme Laboratories Inc. |
|---|---|
| Submitter's address: | 12889 Gregg Court |
| Poway, CA 92064 | |
| Name of Contact Person: | Dr. Abhijit Datta |
| Diazyme Laboratories Inc. | |
| 12889 Gregg Court | |
| Poway, CA 92064 | |
| Phone: 858-455-4762 | |
| Date the Summary was Prepared: | September 28, 2013 |
| Name of the Device | Diazyme 1,5-AG Assay |
| Trade Name: | Diazyme 1,5-AG Assay |
| Common/Usual Name | 1,5-anhydroglucitol(1,5-AG) Assay |
| Device Classification | Assay, Glycosylated Hemoglobin; 21 CFR 864.7470 |
| Product code: | NOZ |
| Panel: | Hematology (81) |
| Submission Type | 510k |
| Regulation Number | 21 CFR 864.7470 |
| Device Class | II |
| Predicate Device: | GlycoMarkTM 1,5-anhydroglucitol (1,5-AG) (K031604). |
| Manufacturing Address | Diazyme Laboratories Inc. |
| 12889 Gregg Court | |
| Poway, CA 92064 | |
| USA | |
| Establishment Registration | 2032900 |
4
DESCRIPTION OF THE DEVICE
Diazyme's 1.5-AG assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphoralated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate.
INDICATIONS FOR USE
Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only.
Substantial Equivalence Information
Predicate device name(s): GlycoMark™ 1,5-anhydroglucitol (1,5-AG) K031604
Comparison of new device to predicate: The tables below identify similarities and differences between the predicate device and the Diazyme 1,5-AG Assay (K180209).
Indications for Use
| GlycoMark™ 1,5-anhydroglucitol (1,5-
AG) (K031604) | Diazyme 1,5-AG Assay
K180209 | Equivalency |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| The GlycoMark™ test provides quantita-
tive measurement of 1,5-anhydroglucitol
(15AG) in serum or plasma. The test is for
professional use, and is indicated for the
intermediate term monitoring of glycemic
control in people with diabetes. | Diazyme 1,5-AG Assay is an enzymatic
method intended for the quantitative de-
termination of 1,5-anhydroglucitol (1,5-
AG) in serum or plasma. The 1,5-AG As-
say is for the intermediate term (preced-
ing 1-2 weeks) monitoring of glycemic
control in people with diabetes. For in
vitro diagnostic use only. | Same |
Assay Principle
| GlycoMark™ 1,5-anhydroglucitol
(1,5-AG) (K031604) | Diazyme 1,5-AG Assay
K180209 | Equivalency |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------|
| The method uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd posi- | Diazyme's 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG | same |
5
| tion hydroxyl group of 15AG and to de- and to detect the generated hydrogen peroxide by |
|---|
| tect the generated hydrogen peroxide by oxide by colorimetry using peroxidase |
| colorimetry using peroxidase (POD). As (POD). To eliminate reactive glucose in |
| PROD reacts with glucose, the sample is sample, it is pretreated by enzymatic reac- |
| pretreated by enzyme reaction using glu- tions using hexokinase and pyruvate ki- |
| cokinase (GK). Glucose is converted nase (PK). Hexokinase uses adenosine tri- |
| into glucose-6-phosphate (G-6-P), a spe- phosphate (ATP) to convert glucose into |
| cies non-reactive with PROD. To drive non-reactive glucose-6-phosphate (G-6- |
| the reaction to completion, an adenosine P), generating adenosine diphosphate |
| triphosphate (ATP)-regenerating system (ADP). The reaction is driven to comple- |
| consisting of pyruvate kinase (PK) and tion with PK, as ADP is phosphoralated to |
| phosphoenol pyruvate (PEP) is utilized. ATP during the conversion of phosphoe- |
| As ATP is converted to adenosine di- nolpyruvate (PEP) into pyruvate. |
| phosphate (ADP), PK, in the presence of |
| PEP, catalyzes the phosphorylation of |
| ADP back to ATP. Following the con- |
| version of glucose to G-6-P, the assay is |
| rendered specific for 15AG. |
Test Objective
| GlycoMark™ 1,5-anhydroglucitol
(1,5-AG) (K031604) | Diazyme 1,5-AG Assay
K180209 | Equivalency |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------|
| For the in vitro quantitative determina-
tion of 1,5-AG in human serum or
plasma. | For the in vitro quantitative determina-
tion of 1,5-AG in human serum or
plasma. | Same |
Type of Test
| GlycoMark™ 1,5-anhydroglucitol
(1,5-AG) (K031604) | Diazyme 1,5-AG Assay
K180209 | Equivalency |
|------------------------------------------------------|---------------------------------|-------------|
| Quantitative | Quantitative | Same |
Specimen Type
| GlycoMark™ 1,5-anhydroglucitol
(1,5-AG) (K031604) | Diazyme 1,5-AG Assay
K180209 | Equivalency |
|------------------------------------------------------|---------------------------------|-------------|
| Human serum or plasma. | Human serum or plasma. | Same |
Product Type
| Product Type | ||
|---|---|---|
| GlycoMark™ 1,5-anhydroglucitol | ||
| (1,5-AG) (K031604) | Diazyme 1,5-AG Assay | |
| K180209 | Equivalency |
6
| Assay reagent kit: liquid stable two rea-
gent system | Assay reagent kit: liquid stable two rea-
gent system | Same |
| ---------------------------------------------------------- | ---------------------------------------------------------- | ------ |
|---|
Performance
| GlycoMarkTM 1,5-anhydroglucitol
(1,5-AG) (K031604) | Diazyme 1,5-AG Assay
K180209 |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Linearity: up to 110 μg/mL | Linearity: up to 110 μg/mL |
| Precision: CV% of 0.8 – 3.8% (2 controls and 2 serum samples) | Precision: CV% of less than 5% |
| Method comparison (vs Roche Tina-
Quant A1c):
89.6% concordance | Accuracy (vs. GlycoMarkTM 1,5-AG):
Correlation Coefficient ( $R^2$ ) = 0.9995, slope = 1.0164, and y intercept = -0.2042. |
Rationale for Considering the Device Substantially Equivalent to Devices Approved for Inter State Commerce
GlycoMark™ 1,5-anhydroglucitol (1,5-AG) (K031604) was selected for method comparison with Diazyme 1,5-AG Assay. The method comparison study between the subject and predicate using clinical patient samples showed excellent correlation. The similarities and differences between the predicate reagent and the Diazyme 1,5-AG Assay are given in the table above. Detailed performance characteristics and comparison analysis are given in the filing and demonstrate substantial equivalence to predicate device. The performance characteristics of the Diazyme 1,5-AG Assay are substantially similar to that of the approved predicate test. Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the Diazyme 1,5-AG Assay and offers users an in vitro diagnostic device system to measure 1.5-AG in human serum and plasma.
Conclusion
Detailed method comparison analysis (accuracy studies) presented in this 510k submission, together with linearity, precision and interference studies, demonstrates that the Diazyme 1,5-AG Assay performance is acceptable, safe and effective. There is no significant deviation between the results obtained by Diazyme 1,5-AG Assay and the legally marketed predicate device GlycoMark™ 1.5-anhydroglucitol (1.5-AG) (K031604) when testing clinical patient samples and is thus substantially similar.
7
PERFORMANCE SUMMARY
Precision Study
In the study, six serum samples were tested following CLSI EP5-A2 protocol.
| Sample | Mean
µg/mL
(N=240) | Within-
Run
SD
CV% | Between-
Run
SD
CV% | Between-
Day
SD
CV% | Between-
Lot
SD
CV% | Total
SD
CV% |
|--------|--------------------------|-----------------------------|------------------------------|------------------------------|------------------------------|--------------------|
| S1 | 3.07 | 0.07
2.3% | 0.07
2.3% | 0.11
3.5% | 0.14
4.7% | 0.15
4.8% |
| S2 | 5.70 | 0.07
1.3% | 0.08
1.4% | 0.07
1.2% | 0.13
2.2% | 0.13
2.2% |
| S3 | 11.56 | 0.09
0.8% | 0.11
1.0% | 0.05
0.5% | 0.15
1.3% | 0.15
1.3% |
| S4 | 23.17 | 0.14
0.6% | 0.15
0.6% | 0.07
0.3% | 0.22
0.9% | 0.22
0.9% |
| S5 | 61.84 | 0.32
0.5% | 0.36
0.6% | 0.42
0.7% | 0.63
1.0% | 0.64
1.0% |
| S6 | 97.26 | 0.48
0.5% | 0.51
0.5% | 0.62
0.6% | 0.93
1.0% | 0.94
1.0% |
Result:
Linearity/Reportable Range
To establish the linearity of the Diazyme 1,5-AG assay, a study design was used based on the CLSI protocol EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach: Approved Guideline.
| Dilution | Recovery Triplicate | Recovery Triplicate | Recovery Triplicate | Recovery Mean (µg/mL) | Expected Recovery (µg/mL) | Error | %Recovery |
|---|---|---|---|---|---|---|---|
| Level 0 | 0.2 | 0.2 | 0.2 | 0.20 | 0.20 | 0% | 100% |
| Level 1 | 10.9 | 10.9 | 11.0 | 10.93 | 11.85 | -8% | 92% |
| Level 2 | 21.8 | 22.2 | 22.4 | 22.13 | 23.49 | -6% | 94% |
| Level 3 | 34.4 | 34.2 | 34.5 | 34.37 | 35.14 | -2% | 98% |
| Level 4 | 45.3 | 45.6 | 45.0 | 45.30 | 46.79 | -3% | 97% |
| Level 5 | 58.4 | 58.7 | 58.5 | 58.53 | 58.43 | 0% | 100% |
| Level 6 | 68.6 | 68.2 | 68.9 | 68.57 | 70.08 | -2% | 98% |
| Level 7 | 80.7 | 81.5 | 81.2 | 81.13 | 81.73 | -1% | 99% |
| Level 8 | 92.5 | 92.7 | 92.9 | 92.70 | 93.37 | -1% | 99% |
| Level 9 | 103.9 | 103.5 | 104.5 | 103.97 | 105.02 | -1% | 99% |
| Level 10 | 116.7 | 116.7 | 116.6 | 116.67 | 116.67 | 0% | 100% |
Result:
8
| Dilution | Recovery Triplicate | | | Recovery
Mean (µg/
mL) | Expected
Recovery
(µg/mL) | Error | %Recovery |
|----------|---------------------|------|------|------------------------------|---------------------------------|-------|-----------|
| Level 0 | 0.1 | 0.1 | 0.3 | 0.17 | 0.17 | 0% | 100% |
| Level 1 | 1.4 | 1.3 | 1.4 | 1.37 | 1.37 | 0% | 100% |
| Level 2 | 2.3 | 2.4 | 2.5 | 2.40 | 2.57 | -6% | 94% |
| Level 3 | 3.5 | 3.6 | 3.4 | 3.50 | 3.77 | -7% | 93% |
| Level 4 | 4.7 | 4.6 | 4.8 | 4.70 | 4.97 | -5% | 95% |
| Level 5 | 5.7 | 5.8 | 5.8 | 5.77 | 6.17 | -6% | 94% |
| Level 6 | 7.0 | 7.1 | 7.0 | 7.03 | 7.37 | -5% | 95% |
| Level 7 | 8.3 | 8.2 | 8.2 | 8.23 | 8.57 | -4% | 96% |
| Level 8 | 9.4 | 9.5 | 9.6 | 9.50 | 9.77 | -3% | 97% |
| Level 9 | 10.9 | 10.9 | 10.8 | 10.87 | 10.97 | -1% | 99% |
| Level 10 | 12.2 | 12.2 | 12.1 | 12.17 | 12.17 | 0% | 100% |
The Diazyme 1,5-AG Assay is linear up to 116.7 µg/mL, and also in the clinically relevant range of 0.6- 10.0 µg/mL 1.5-AG.
LoB/LoD/LoQ
The Limit of Blank (LoB), the Limit of Detection (LoD) and the Limit of Quantitation (LoQ) of the Diazyme 1,5-AG assay were determined according to CLSI EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline using three lots of the reagents on Beckman AU680. The LOB was determined to be 0.3 µg/mL; the LOD was determined to be 0.5 µg/mL; the LOQ was determined to be 0.6 µg/mL.
Analytical specificity
To determine the level of interference from the substances normally present in the patient samples, Diazyme 1,5-AG Assay was used to test low (5.0 µg/mL), medium (23.0 µg/mL), and high (50 ug/mL) 1,5-AG samples with various concentrations of substances following CLSI EP7-A2.
The following substances normally present in the samples produced less than 10% deviation when tested at levels equal to the concentrations listed below.
| Interference Substances | Concentration |
|---|---|
| Free Bilirubin | 5 mg/dL |
| Bilirubin Conjugated | 5 mg/dL |
| Hemoglobin | 125 mg/dL |
| Ascorbic Acid | 37.5 mg/dL |
| Triglyceride | 1000 mg/dL |
| Glucose | 1000 mg/dL |
| Maltose | 500 mg/dL |
| Uric Acid | 20 mg/dL |
| Creatinine | 10 mg/dL |
| Urea | 20 mg/dL |
9
Comparison Studies
Protocol: Clinical and Laboratory Standards Institute EP9-A2 - Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline-Second Edition (2002). For method comparison, the 1,5- AG Assay was evaluated by testing individual serum samples with comparison to predicate legally marketed 1,5- AG device. A total of 102 patient samples covering the AMR were tested by both 1,5- AG Assay and Predicate 1,5- AG Assay.
Result:
| Parameter | Results | ||
|---|---|---|---|
| Slope | 1.0164 | ||
| 95% CI | 1.012 to 1.021 | ||
| Intercept | -0.21 | ||
| 95% CI | -0.35 to -0.07 | ||
| Standard Error of Estimate | 0.51 | ||
| Correlation Coefficient(R) | 0.9997 | ||
| R2 | 0.9995 |
Reference Range Study
To determine the reference interval of the normal population, serum samples from 140 apparently healthy males and 140 apparently healthy females were tested using the 1,5- AG Assay according to CLSI C28-A3 guideline.
Using non-parametric 5th 95th percentiles, the reference interval for males was established to be 8.19 to 32.19 µg/mL and 6.00 to 29.10 µg/mL for females.