(184 days)
No
The description focuses on standard chemical analysis techniques and automated laboratory processes, with no mention of AI or ML.
No.
The device is an in vitro diagnostic (IVD) chemistry analyzer used to measure glucose levels in serum for diagnostic purposes, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use..."
No
The device description clearly details a physical chemistry analyzer (IR-1200) with hardware components like an optical unit, pipetting system, and electronic system, in addition to the reagent. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "for the in vitro quantitative measurement of glucose in serum" and "intended for in vitro diagnostic use". It also describes how the measurements are used in the "diagnosis and treatment" of various conditions.
- Device Description: The description details a reagent and an analyzer designed to perform chemical tests on biological samples (serum).
- Performance Studies: The document outlines analytical performance studies (precision, linearity, specificity, detection limit, comparison studies) which are standard for evaluating the performance of IVD devices.
- Intended User/Care Setting: The device is intended for use in "clinical laboratories," which is a typical setting for IVD testing.
The entire context of the document points to a device designed to be used outside of the body (in vitro) to diagnose or aid in the diagnosis of medical conditions.
N/A
Intended Use / Indications for Use
The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose in serum on the Synermed IR-1200 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbolygrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.
The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random eccess, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.
Product codes
CGA, JJE
Device Description
Synermed IR-1200 Glucose Reagent
The Synermed Glucose is ready to use. The composition of the Synermed Glucose Oxidase Reagent is as follows: 280 umol/L N-sulfopropyl-N-ethyl-3, 5-dimethylaniline, 280 umol/L ampyrone, 1400 U/L peroxidase (horseradish) and 18,000 U/L glucose oxidase.
Synermed IR-1200 Chemistry Analyzer
The IR-1200 Chemistry Analyzer is a multiparameter chemistry instrument that quantitates the levels of analytes in serum using spectrophotometric measurement. The system uses Synermed liquid-stable reagent systems that have been previously cleared by FDA.
The IR-1200 Chemistry Analyzer is a discrete analyzer with STAT priority capabilities and an externalized computer. The instrument features a user-friendly software operating system, optical unit, precision pipetting and electronic system. Twelve wavelengths are included ranging from 340 nm to 800 nm. The instrument's capabilities include: sample pipetting, reagent pipetting, anti-interference, mixing, pre-heating, reaction monitoring, calculation, display and printing of results. After the measurement is complete, the system rinses and dries the cuvettes. The system automates the manual functions and, as a result, it enhances efficiency, diminishes errors, thus improving the accuracy and precision of test results.
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
clinical laboratories
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)
The purpose of the performance studies was to validate that the previously cleared reagents have the same performance characteristics on the proposed new analyzer (Synermed IR-1200) as compared to the previously cleared Hitachi 717. The sponsor has chosen the representative analyte Glucose using serum as the representative sample matrix.
Analytical Performance
a. Precision/Reproducibility
Study Type: Verification of precision
Sample Size: 80 measurements at each of 5 concentrations of pooled patient serum for glucose.
Key Results: Mean, standard deviation and coefficient of variation were determined for glucose at each concentration. Percentage of imprecision and total error was calculated.
| Mean (mg/dL glucose) | Within Run Precision S.D. (mg/dL) | Within Run Precision C.V. (%) | Total Precision S.D. (mg/dL) | Total Precision C.V. (%) |
|---|---|---|---|---|
| 44.6 | 0.25 | 0.5% | 0.5 | 1.2% |
| 120.7 | 1.35 | 1.1% | 1.7 | 1.4% |
| 180.8 | 1.74 | 0.9% | 2.1 | 1.1% |
| 375.2 | 0.6 | 0.1% | 0.8 | 0.2% |
| 626.03 | 0.6 | 0.09% | 0.8 | 0.1% |
b. Linearity/Reportable Range
Study Type: Linearity studies
Sample Size: Samples prepared by intermixing a high serum pool with a low serum pool to obtain thirteen concentrations across the measuring range with four replicates at each concentration.
Key Results: Observed values were compared to the expected values and linear regression results are summarized.
| Measurand | Slope | Intercept | R2 | Sample Range Tested | Claimed Measuring Range |
|---|---|---|---|---|---|
| Glucose (mg/dL) | 0.9928 | 1.3499 | 0.9999 | 6.5-900 | 8-885 |
c. Analytical Specificity
Study Type: Interference studies
Key Results: Effects of common endogenous substances (bilirubin, hemoglobin, triglycerides, uric acid) and common medications (ascorbic acid, acetaminophen, gentamicin, ibuprofen, L-dopa, methyldopa, N-acetylcysteine, ofloxacin, salicyluric acid, tetracycline) were evaluated. Significant interference defined as bias ≥ 10%.
Interfering substances identified: ascorbic acid, methyldopa, levofloxacin, salicyluric acid, uric acid.
| Interferent | Interferent Concentration | % Bias Seen at Glucose 80mg/dL | % Bias Seen at Glucose 120mg/dL |
|---|---|---|---|
| Ascorbic Acid | 6.02mg/dL | -11.7 | -13.0 |
| Methyldopa | 14.99ug/mL | -10 | -11.1 |
| Salicyluric Acid | 0.6ug/mL | -13.7 | -8.7 *not significant |
| Uric Acid | 23.54mg/dL | -10.7 | -11.5 |
d. Detection Limit
Study Type: Evaluation of Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ).
Key Results:
| Measurand | LoB | LoD | LoQ | Claimed Range |
|---|---|---|---|---|
| Glucose (Serum) (mg/dL) | 2.8 | 3.65 | 8.0 | 8-885 |
e. Comparison Studies
Study Type: Method comparison
Sample Size: 115 samples for glucose. 15 of 115 samples were modified to cover the entire claimed measuring range.
Key Results: Samples tested on the IR-1200 and Hitachi 717 chemistry analyzers.
| Test | Sample Type | Total # Samples | Sample Range Tested | Claimed Measuring Range | Slope | Intercept | Correlation Coefficient |
|---|---|---|---|---|---|---|---|
| Glucose mg/dL | Serum | 115 | 15-885 | 8-885 | 0.988 | -0.178 | 0.9994 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: Slope = 0.9928, Intercept = 1.3499, R2 = 0.9999
Method Comparison: Correlation Coefficient = 0.9994
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) JULIE PASCHAL REGULATORY AFFAIRS SPECIALIST 17408 TILLER COURT SUITE 1900 WESTFIELD IN 40674
June 24, 2016
Re: K153692
Trade/Device Name: Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer Regulation Number: 21 CFR 8862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, JJE Dated: June 20, 2016 Received: June 21, 2016
Dear Ms. Paschal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
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Indications for Use
510(k) Number (if known) K153692
Device Name Synermed Glucose Reagent Synermed IR-1200 Chemistry Analyzer
Indications for Use (Describe)
The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose in serum on the Synermed IR-1200 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbolygrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.
The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random eccess, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.
| 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
1. Company Information
Infrared Laboratory Systems, LLC 17408 Tiller Court Suite 1900 Westfield, Indiana 46074 Telephone; (317) 896-1565 FAX: (317) 896-1566
2. Contact Information
Julie Paschal Regulatory Affairs Specialist Telephone: 336-235-3057 Email: jpaschal(@slplabs.com
-
- Date Prepared: June 20, 2016
-
- Device Trade Name: Synermed Glucose Reagent; Synermed IR-1200 Chemistry Analyzer
-
- Common Name: Glucose test system; Chemistry Analyzer
-
- Classification Name: Glucose test, Class II; Discrete photometric chemistry analyzer for
clinical use, Class I
-
- Classification Regulation: 21CFR862.1345, 21CFR862.2160
8. Classification Product Code: CGA, JJE
-
- Panel: Chemistry (75)
10. Reagent Device Classification:
| Pro
Code | Classification
Regulation | Classification Name | Device Class | Panel |
|-------------|------------------------------|----------------------------------------------------------------|--------------|-------|
| CGA | 862.1345 | Glucose test system | Class II | 75 |
| JJE | 862.2160 | Discrete photometric
chemistry analyzer for
clinical use | Class I | 75 |
4
| K-number | Manufacturer | Product |
|---|---|---|
| K872494 | Boehringer | |
| Mannheim | ||
| Corp (Roche) | Hitachi 717 | |
| chemistry | ||
| analyzer | ||
| K903063 | Synermed | Synermed |
| Glucose | ||
| Reagent |
11. Identification of Predicates:
12. Device Description
Synermed IR-1200 Glucose Reagent
The Synermed Glucose is ready to use. The composition of the Synermed Glucose Oxidase Reagent is as follows: 280 umol/L N-sulfopropyl-N-ethyl-3, 5-dimethylaniline, 280 umol/L ampyrone, 1400 U/L peroxidase (horseradish) and 18,000 U/L glucose oxidase.
Synermed IR-1200 Chemistry Analyzer
The IR-1200 Chemistry Analyzer is a multiparameter chemistry instrument that quantitates the levels of analytes in serum using spectrophotometric measurement. The system uses Synermed liquid-stable reagent systems that have been previously cleared by FDA.
The IR-1200 Chemistry Analyzer is a discrete analyzer with STAT priority capabilities and an externalized computer. The instrument features a user-friendly software operating system, optical unit, precision pipetting and electronic system. Twelve wavelengths are included ranging from 340 nm to 800 nm. The instrument's capabilities include: sample pipetting, reagent pipetting, anti-interference, mixing, pre-heating, reaction monitoring, calculation, display and printing of results. After the measurement is complete, the system rinses and dries the cuvettes. The system automates the manual functions and, as a result, it enhances efficiency, diminishes errors, thus improving the accuracy and precision of test results.
13. Intended Use
Synermed Glucose Reagent
The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose on serum on the Synermed IR-1200. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma.
Synermed IR-1200 Chemistry Analyzer
The Synermed IR-1200 analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random access, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.
5
14. Comparison of Technological Characteristics with the Predicate Device
The new device is substantially equivalent to the predicate because it has the same intended use and has the same or similar technological characteristics including safety and effectiveness. The same specimen type can be analyzed and both analyzers use spectrophotometry to detect the amount of absorbance which is proportional to the concentration of the analyte in the specimen. Both analyzers wash and reuse PMMA cuvettes as well as use temperature ranges and the incubation for the reaction occurs at 37°C. Analyzer performance was quantified using the same previously cleared reagent systems.
6
| Items | Candidate Device: Synermed IR-1200 Chemistry Analyzer | Predicate Device:
Roche/Boehringer
Mannheim
Hitachi 717
Chemistry
Analyzer |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| | Similarity/Difference | |
| Intended Use | The Synermed IR-1200 chemistry analyzer
is an automated clinical analyzer for in
vitro diagnostic use only in clinical
laboratories. It is intended to be used for a
variety of assay methods. The analyzer
provides in vitro quantitative
determinations for glucose in serum
samples. | Same |
| Environment | Clinical laboratory use only | Same |
| Specimen | Serum | Same |
| Power | 220 VAC, 50/60 Hz | 115 VAC, 60 Hz |
| Analytical Methods | Endpoint, kinetic | Same |
| Calibration Methods | Linear and Nonlinear calibration | Same |
| Throughput (Max) | 800 photometric tests/ hour | 600 photometric
tests/ hour |
| Calibration/QC | Programmable Cal/QC, will repeat
automatically if out of range | Same |
| Photometer wavelength | 340-800 (12 wavelengths) | Same |
| Linear Absorbance Range | 0-3.3 Absorbance | 0-3.2 Absorbance |
| Reaction Cuvettes | Reusable PMMA (Polymethylmethacrylate) | Same |
| Lightpath | 0.5cm | 0.6cm |
| Sample Volume | 1.5-35μL | 1-20μL |
| Reagent Volume | 15-350μL | 50-350μL |
| Reaction Volume | 120-450μL | 250-400μL |
Differences
The Synermed IR-1200 can use smaller reagent and sample volumes than the Hitachi 717. The Synermed IR-1200 is smaller and weighs less than the Hitachi 717. The Synermed IR-1200 can use up to 4 reagents to perform an analysis while the Hitachi 717 can only use 2 reagents.
7
| Items | Candidate Device: Synermed
IR-1200 Glucose Reagent | Predicate Device: Synermed Glucose
Reagent |
|-----------------------|-------------------------------------------------------------|---------------------------------------------------------------------|
| Similarity/Difference | | |
| Intended Use | For the quantitative
measurement of glucose in
serum. | For the quantitative measurement
of glucose in serum and plasma. |
| Test Principle | Oxidase | Same |
| Sample Type | Serum | Serum and Plasma |
| Measuring Range | 8-885 mg/dL | Same |
15. Summary of Performance Testing
The purpose of the performance studies was to validate that the previously cleared reagents have the same performance characteristics on the proposed new analyzer (Synermed IR-1200) as compared to the previously cleared Hitachi 717. The sponsor has chosen the representative analyte Glucose using serum as the representative sample matrix.
Analytical Performance
a. Precision/Reproducibility
Verification of precision on the Synermed IR-1200 was accomplished by implementing the study protocol laid out in CLSI document EP05-A3. Five concentrations of pooled patient serum were run for glucose. Each aliquot was run in duplicate twice a day for twenty days for a total of 80 measurements at each concentration. The mean, standard deviation and coefficient of variation were determined for glucose at each concentration. Additionally, the percentage of imprecision and total error was calculated. The results are displayed in the tables below.
Results:
| Within Run Precision | Total Precision | |||
|---|---|---|---|---|
| Mean | ||||
| (mg/dL glucose) | S.D. | |||
| (mg/dL) | C.V. | |||
| (%) | S.D. | |||
| (mg/dL) | C.V. | |||
| (%) | ||||
| 44.6 | 0.25 | 0.5% | 0.5 | 1.2% |
| 120.7 | 1.35 | 1.1% | 1.7 | 1.4% |
| 180.8 | 1.74 | 0.9% | 2.1 | 1.1% |
| 375.2 | 0.6 | 0.1% | 0.8 | 0.2% |
| 626.03 | 0.6 | 0.09% | 0.8 | 0.1% |
Figure 1 - Glucose Mean, Standard Deviation & %CV for all 80 Results
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b. Linearity/Reportable Range
Linearity studies were designed using CLSI EP06-A. Samples were prepared by intermixing a high serum pool with a low serum pool to obtain thirteen concentrations across the measuring range with four replicates at each concentration. The observed values were compared to the expected values and the results of linear regression are summarized below.
Linearity Results:
| Measurand | Slope | Intercept | R2 | Sample Range
Tested | Claimed Measuring
Range |
|-----------------|--------|-----------|--------|------------------------|----------------------------|
| Glucose (mg/dL) | 0.9928 | 1.3499 | 0.9999 | 6.5-900 | 8-885 |
Calibrators
The Synermed IR Cal II was previously cleared in K940571 and is traceable to NIST standard number 917-C; no modification was made.
c. Analytical Specificity
Interference studies were performed according to CLSI EP07-A2. Effects of common endogenous substances including bilirubin, hemoglobin, triglycerides and uric acid were evaluated by spiking serum pools with interferent at two analyte levels and at two concentrations of interferent. Additionally, common medications known to potentially affect the glucose assav were also tested at two analyte levels and at two concentrations of interferent. The sponsor defined significant interference as a bias of ≥=10% between the spiked and unspiked samples. Finally, any substance seen to interfere with the glucose assav was further studied using the dose-response procedure laid out on CLSI EP07-A2. Synermed will still reference in the product insert Young, D.S., Effects of Drugs on Clinical Laboratory Tests, 5th ed. Vol.2 AACC Press, Washington, D.C., 2000. The test results are summarized below:
Effects of common endogenous substances including conjugated bilirubin (0.76 and 20 mg/dL), unconjugated bilirubin (0.76 and 20mg/dL), hemoglobin (100 and 500 mg/dL), triglycerides (176.99 and 3274.34mg/dL) and uric acid (11.77 and 23.54mg/dL) were evaluated at two different glucose concentrations (80 mg/dL and 120 mg/dL) for interference. Furthermore, the following exogenous substances: ascorbic acid (1.22 and 6.02mg/dL), acetaminophen (20.11 and 200.18ug/mL), genatmicin (7.51 and 10.05ug/mL), ibuprofen (40.08 and 500.21ug/mL), L-dopa (0.41 and 1.24µg/ml/L), methyldopa (4.24 and 14.99µg/mL), N-acetylcysteine (0.08 and 0.25mg/dL), ofloxacin (8.78 and 17.5mg/L), salicyluric acid 0.2 and 0.6ug/mL), tetracycline (3.78 and 16.27ug.mL) were evaluated at two different glucose concentrations (80 mg/dL and 120 mg/dL) for interference. The sponsor defined non-significant interference when the bias between the tested and control samples are within +/-10%.
The sponsor identified ascorbic acid, methyldopa, levofloxacin, salicyluric acid, uric acid as interferants (see table).
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Figure 2 - Results Summary, Dose-Response
The Synermed Glucose measurement procedure was evaluated for interference according to CLSI document EP07-A2. The following study results demonstrate that the following substances do not interfere with the Synermed Glucose assay at the highest concentration listed. A bias of