(233 days)
No
The description details a chemical assay and spectrophotometric analysis with calculations based on a pre-programmed calibration curve from an RFID card. There is no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) test kit used for the quantitative determination of glycated serum proteins to monitor diabetic patients, not to treat them.
Yes
The device is intended for the quantitative determination of glycated serum proteins in serum, which is useful for monitoring diabetic patients, directly indicating its purpose in diagnosing or monitoring a medical condition.
No
The device description clearly outlines hardware components including a spectrophotometer (SMART Analyzer), reagent cuvettes, and caps, which are integral to the device's function. While software is used for calculations and controlling the analyzer, it is not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is a clear declaration of its intended purpose.
- Function: The device is designed to quantitatively determine glycated serum proteins (GSP; fructosamine) in serum. This is a measurement performed on a biological sample (serum) outside of the body to provide information for the diagnosis or monitoring of a medical condition (diabetes).
- Monitoring Diabetic Patients: The intended use also states that the measurement is "useful for monitoring diabetic patients," which is a common application of IVD devices.
- Device Description: The description details the biochemical reactions and measurement method used to analyze the serum sample, which is characteristic of an IVD assay.
- Components: The system includes reagents and a specialized analyzer designed to work with those reagents to perform the diagnostic test.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Diazyme Glycated Serum Protein POC Test Kit is intended for the quantitative determination of glycated serum proteins (GSP; fructosamine) in serum. Fructosamine is representative of blood glucose levels over the course of 2-3 weeks. The measurement of glycated serum proteins is useful for monitoring diabetic patients. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
The Diazyme Glycated Serum Protein POC Assay uses proteinase K to digest GSP into low molecular weight glycated protein fragments (GPF), and uses Diazyme's specific fructosamiase™, a microorganisms originated amadoriase to catalyze the oxidative degradation of Amadori product GPF to yield peptide fragments (PF) or amino acids, glucosone and H2O2. The H2O2 released is measured by a colorimetric Trinder end-point reaction. The absorbance at 546 nm is proportional to the concentration of glycated serum proteins. The SMART analyzer calculates the GSP concentrations of patient serum specimens by use of a lot specific calibration curve. The lot specific curve is represented in a Calibration card (RFID) provided with each GSP POC Test Kit.
SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 40ul of sample to the DRS cuvette prefilled with R1 containing proper buffer. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 546nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and lot specific calibration curve.
The Diazyme GSP POC Test Kit system thus consists of the following:
- . GSP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
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
Adults (>18 years) have a reported normal range of 191-289 umol/L.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Study:
The precision of the Diazyme GSP Assay was evaluated according to CLSI EP5-A guideline. In the study, 5 serum samples containing about 87, 226, 479, 743, and 1243 umol/L fructosamine, respectively, were tested 2 runs per day in duplicates over 20 working days.
Key results:
Serum Level 1 (n=80, Mean=87 mg/L): Within Run CV=6.1%, Total CV=5.6%
Serum Level 2 (n=80, Mean=226 mg/L): Within Run CV=4.3%, Total CV=4.5%
Serum Level 3 (n=80, Mean=479 mg/L): Within Run CV=3.4%, Total CV=3.4%
Serum Level 4 (n=80, Mean=743 mg/L): Within Run CV=1.6%, Total CV=2.5%
Serum Level 5 (n=80, Mean=1243 mg/L): Within Run CV=1.5%, Total CV=1.8%
Linearity/assay reportable range:
Twelve levels of linearity set were prepared by diluting a sample containing 1348 umoVL Fructosamine with low sample with 2 umol/L Fructosamine according to CLSI EP6-A and analyzed on SMART Analyzer. Results indicated linearity from 2 to 1348 umol/L. Allowable systematic error (SEA) was 4.9%.
Comparison studies:
A total of forty nine serum specimens were tested with Diazyme GSP POC Test on SMART analyzer. The correspondent plasma samples were tested with Diazyme GSP Assay on Hitachi 917 analyzer (predicate K110188).
n = 54
Slope = 0.9737 (95%CI:0.95599-0.9944)
Intercept (µmol/L) = 0.6859 (95% CI: -4.7287-7.8918)
Correlation coefficient, r = 0.9975 (95%CI:0.9956-0.9985)
Range of values (µmol/L) = 70.0 to 1269
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LOB = 12 umol/L
LOD = 30 umol/L
LOQ = 61 umol/L
Linear Range: 61 to 1348 µmol/L
Within precision ≤ 5.6 % CV
Total Precision: ≤ 6.1 % CV
Accuracy: Correlation Coefficient: 0.99, Slope/Intercept: y = 0.97/ 0.69
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DIAZYME LABORATORIES DR. ABHIJIT DATTA 12889 GREGG COURT POWAY CA 92064
August 6, 2014
Re: K133803
Trade/Device Name: Diazyme Glycated Serum Protein POC Test Kit Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP Dated: July 9, 2014 Received: July 10, 2014
Dear Dr. 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. 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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Katherine Serrano -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
2
Indications for Use
510(k) Number (if known) K133803
Device Name Diazyme Glycated Serum Protein POC Test Kit
Indications for Use (Describe)
The Diazyme Glycated Serum Protein POC Test Kit is intended for the quantitative determination of glycated serum proteins (GSP; fructosamine) in serum. Fructosamine is representative of blood glucose levels over the course of 2-3 weeks. The measurement of glycated serum proteins is useful for monitoring diabetic patients. 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) SUMMARY & SUBSTANTIAL EQUIVALENCE COMPARISON
Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Submitter's name: | Diazyme Laboratories |
|---|---|
| Submitter's address: | 12889 Gregg Court |
| Poway, CA 92064 | |
| USA | |
| Name of Contact Person: | Dr. Abhijit Datta |
| Diazyme Laboratories | |
| 12889 Gregg Court | |
| Poway, CA 92064 | |
| Phone: 858-455-4762 | |
| Fax: 858-455-2120 | |
| abhijit.datta@diazyme.com | |
| Date the Summary was Prepared | July 9, 2014 |
| Name of Device | Diazyme Glycated Serum Protein POC Test Kit |
| Trade Name | Diazyme GSP POC Test Kit |
| Common/Usual Name | Diazyme GSP POC Test Kit |
| Device Classification Name | Assay, Glycosylated Hemoglobin |
| Product Code | LCP |
| Panel | Clinical Chemistry |
| Submission Type | Traditional 510k |
| Regulation Number | 864.7470 - Glycosylated hemoglobin assay |
| Device Class | Class II |
4
| Predicate Device | Diazyme Glycated Serum Protein (GSP) Assay
(K110188)
Diazyme Glycated Serum Protein Calibrator Kit
(K110188)
Diazyme Glycated Serum Protein Control Kit
(K110188) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Address | Diazyme Laboratories
12889 Gregg Court
Poway, CA 92121
USA |
| Establishment Registration | 2032900 |
Executive Summary
Detailed performance characteristics and comparison analysis are given in this filing that demonstrates substantial equivalence of the GSP POC Assay Kit to predicate device that is currently being marketed. The performance characteristics of the GSP POC Assay Kit are substantially similar to that of the approved predicate device (K110188). Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the GSP POC Assay and offers POL users an in vitro diagnostic device system to measure GSP in human serum samples.
Device Description:
Clinical Significance
Fructosamine is formed due to a non-enzymatic Maillard reaction between glucose and amino acid residues of serum proteins. It is reported in medical literature that 80% of measured glycated serum proteins are glycated albumins. In diabetic patients, elevated blood glucose levels correlate with increased fructosamine formation. Glycated serum proteins (GSP; fructosamine) are a medium term indicator of diabetic control (2-3 weeks).
Assay Principle
The Diazyme Glycated Serum Protein POC Assay uses proteinase K to digest GSP into low molecular weight glycated protein fragments (GPF), and uses Diazyme's specific fructosamiase™, a microorganisms originated amadoriase to catalyze the oxidative degradation of Amadori product GPF to yield peptide fragments (PF) or amino acids, glucosone and H2O2. The H2O2 released is measured by a colorimetric Trinder end-point reaction. The absorbance at 546 nm is proportional to the concentration of glycated serum proteins. The SMART analyzer calculates the GSP concentrations of patient serum specimens by use of a lot specific calibration curve. The lot specific curve is represented in a Calibration card (RFID) provided with each GSP POC Test Kit.
5
SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 40ul of sample to the DRS cuvette prefilled with R1 containing proper buffer. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 546nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and lot specific calibration curve.
The Diazyme GSP POC Test Kit system thus consists of the following:
- . GSP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
Indications for Use
The Diazyme Glycated Serum Protein POC Test Kit is intended for the quantitative determination of glycated serum proteins (GSP; fructosamine) in serum. Fructosamine is representative of blood glucose levels over the course of 2-3 weeks. The measurement of glycated serum proteins is useful for monitoring diabetic patients. For in vitro diagnostic use only.
Indications for Use
| Predicate K110188 | Candidate device | Equivalency |
|---|---|---|
| Diazyme Glycated Serum Protein | ||
| Assay Kit in conjunction with Diazyme | ||
| Glycated Serum Protein single | ||
| calibrator, are intended for the | ||
| quantitative determination of glycated | ||
| serum proteins (GSP; glycated | ||
| albumins; fructosamine) in serum. The | ||
| measurement of glycated serum | ||
| proteins is useful for monitoring | ||
| diabetic patients | The Diazyme Glycated Serum Protein | |
| POC Test Kit is intended for the | ||
| quantitative determination of glycated | ||
| serum proteins (GSP; fructosamine) in | ||
| serum. Fructosamine is representative | ||
| of blood glucose levels over the course | ||
| of 2-3 weeks. The measurement of | ||
| glycated serum proteins is useful for | ||
| monitoring diabetic patients. For in | ||
| vitro diagnostic use only. | Similar |
6
| Predicate K110188 | Candidate device | Equivalency |
|---|---|---|
| The Diazyme Glycated Serum Protein | ||
| Assay uses Proteinase K to digest Gly- | ||
| cated Serum Proteins (GSP) into low | ||
| molecular weight glycated protein | ||
| fragments (GPF), and uses Diazyme's | ||
| specific fructosaminaseTM, a microor- | ||
| ganism originated amadoriase to cata- | ||
| lyze the oxidative degradation of | ||
| Amadori product GPF to yield PF or | ||
| amino acids, glucosone and H2O2. The | ||
| H2O2 released is measured by a color- | ||
| imetric Trinder end-point reaction. The | ||
| absorbance at 600 nm is proportional to | ||
| the concentration of glycated serum | ||
| proteins. | The Diazyme Glycated Serum Protein | |
| POC Assay uses proteinase K to digest | ||
| GSP into low molecular weight gly- | ||
| cated protein fragments (GPF), and us- | ||
| es Diazyme's specific fructosami- | ||
| aseTM, a microorganisms originated | ||
| amadoriase to catalyze the oxidative | ||
| degradation of Amadori product GPF to | ||
| yield peptide fragments (PF) or amino | ||
| acids, glucosone and H2O2. The H2O2 | ||
| released is measured by a colorimetric | ||
| Trinder end-point reaction. The absorb- | ||
| ance at 546 nm is proportional to the | ||
| concentration of glycated serum pro- | ||
| teins. The SMART analyzer calculates | ||
| the GSP concentrations of patient se- | ||
| rum specimens by use of a lot specific | ||
| calibration curve. The lot specific curve | ||
| is represented in a Calibration card | ||
| (RFID) provided with each GSP POC | ||
| Test Kit. | Similar |
Principle
Test Objective
| Predicate K110188 | Candidate device | Equivalency |
|---|---|---|
| For the in vitro quantitative determina- | ||
| tion of glycated serum proteins (GSP; | ||
| glycated albumins; fructosamine) in | ||
| human serum. | For the in vitro quantitative deter- | |
| mination of glycated serum proteins | ||
| (GSP; glycated albumins; fructosamine) | ||
| in human serum. | Same |
Type of Test
| Predicate K110188 | Candidate device | Equivalency |
|---|---|---|
| Quantitative | Quantitative | Same |
Methodology
| Predicate K110188 | Candidate device | Equivalency |
|---|---|---|
| Enzymatic method | Enzymatic method | Same |
7
Specimen
| Predicate K110188 | Candidate device | Equivalency |
|---|---|---|
| Human serum | Human serum | Same |
Product Type
| Predicate K110188 | Candidate device | Equivalency |
|---|---|---|
| 2 Reagents Liquid (ready-to-use) | Prefilled ready to use DRS Cuvettes, lot | |
| specific RFID calibration card | Similar |
Performance
| Predicate K110188 | Candidate device |
|---|---|
| Linear Range: up to 1354 µmol/L | Linear Range: 61 to 1348 µmol/L |
| Precision: | |
| Within: 18 years) have a reported normal range of 191-289 umol/L. It is recommended that each laboratory establish its own reference range to reflect the age, sex, diet and geographical location of the population. |