(252 days)
No
The device description and performance studies focus on standard enzyme immunoassay technology and analytical chemistry methods. There is no mention of AI or ML in the intended use, device description, or performance evaluation sections.
No.
This device is an in vitro diagnostic (IVD) assay intended for the qualitative and semi-quantitative determination of opiates in human urine. It is used to provide preliminary analytical results for identifying opiates and is not intended for treatment or alleviation of a disease.
Yes
The device is intended for the qualitative and semi-quantitative determination of opiates in human urine, providing a preliminary analytical result for drug testing, which is a diagnostic purpose.
No
The device description clearly states it is a "ready to use" reagent composed of specific chemical components (Antibody/Substrate Reagent and Enzyme-drug Conjugate Reagent). This indicates a physical, chemical-based assay, not a software-only device.
Based on the provided information, the Synermed Enzyme Immunoassay is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative determination of opiates in human urine." This involves testing a biological sample (urine) outside of the body to gain information about a person's health status (presence of opiates).
- Device Description: The device is a "ready to use" reagent kit containing antibodies, enzymes, and other chemical components designed to react with substances in the urine sample. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes performance studies like precision, linearity, analytical specificity, and comparison studies, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Comparison to Predicate Device: The mention of a predicate device (K110298; Lin-Zhi International Enzyme Immunoassay, Opiate) further confirms its classification as an IVD, as predicate devices are used in the regulatory process for new IVDs.
- Professional Use: While not exclusively defining an IVD, the indication for "professional use" aligns with the typical use of diagnostic tests in a clinical or laboratory setting.
Therefore, the Synermed Enzyme Immunoassay fits the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synermed Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. This assay is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmatory method such as GCMS or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liguid Chromatography/Mass Spectrometry (GC/MS or LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Product codes
DJG
Device Description
The Synermed Opiate Enzyme Immunoassay Reagent is ready to use. The composition of the Synermed Opiate Enzyme Immunoassay Reagent is as follows:
Antibody/Substrate Reagent (R1): Contains mouse monoclonal anti-morphine antibody, opiate-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative.
Enzyme-drug Conjugate Reagent (R2): Contains morphine-labeled opiate-6-phosphate dehydrogenase (G6PDH) in buffer with sodium azide (0.09 %) as a preservative.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use with a number of automated clinical chemistry analyzers.
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-500) as compared to the previously cleared Hitachi 717. The sponsor has chosen the representative analyte Opiate using urine as the representative sample matrix.
Analytical Performance
a. Precision/Reproducibility
Verification of semi-quantitative precision on the Synermed IR-500 was accomplished by implementing the study protocol laid out in NCCLS document EP05-A3, Chapter 3. Qualitative verification was accomplished by implementing the study protocol laid out in CLSI EP12-A, Chapter 7. Eleven concentrations of pooled human urine were run for opiate. 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 opiate at each concentration. For qualitative analysis, the results were compared to the expected result (negative expected results should yield negative results in the precision study). Each level of pooled human urine was confirmed by Ultra High-Performance Liquid Chromatography Tandem Mass Spectrometry, for verification chromatography refer to Appendix A: UHPLC-MSMS Raw Data.
b. Linearity/Reportable Range
Linearity studies were designed using NCCLS EP06-A. Samples were prepared by intermixing a high urine pool with a low urine pool to obtain ten concentrations across the measuring range with four replicates at each concentration. The observed values were compared to the expected values and are summarized below. Each level of pooled human urine was confirmed by Ultra High-Performance Liquid Chromatography Tandem Mass Spectrometry.
c. Analytical Specificity
The following endogenous compounds were spiked into urine spiked with morphine to +/- 25% of cutoff (225 and 375 ng/mL). The spiked solutions were evaluated on the IR-500. The substances listed in the following table were determined not to interfere at the concentrations tested.
d. Comparison Studies
Method comparison was performed according to CLSI EP09-A3, 100 samples for opiate were tested on the IR-500, Hitachi 717 chemistry analyzers, and Ultra High-Performance Liquid Chromatography Tandem Mass Spectrometry (LC-MSMS). The study results are summarized in the table below. Each level of pooled human urine was confirmed by Ultra High-Pressure Liquid Chromatography Tandem Mass Spectrometry, for verification chromatography refer to Appendix A: UHPLC-MSMS Raw Data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
April 19, 2018
Infrared Laboratory Systems, LLC (dba Synermed) Julie Paschal Regulatory Affairs Specialist 17408 Tiller Court, Suite 1900 Westfield, IN 40674
Re: K172416
Trade/Device Name: Synermed Opiate Enzyme Immunoassay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: February 28, 2018 Received: March 5, 2018
Dear Julie 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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
Enclosure
2
Indications for Use
510(k) Number (if known) K172416
Device Name Synermed Opiate Enzyme Immunoassay
Indications for Use (Describe)
The Synermed Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. This assay is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmatory method such as GCMS or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/ MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
| 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
K172416 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: 336-269-5069 Email: jpaschal@slplabs.com
-
- Date Prepared: August 3rd 2017
-
- Device Trade Name: Synermed Opiate Enzyme Immunoassay
-
- Common Name: Opiate Enzyme Immunoassay
-
- Classification Name: Enzyme Immunoassay, Opiate
-
- Classification Regulation: 21CFR862.3650
-
- Classification Product Code: DJG
-
- Panel: Toxicology (91)
10. Reagent Device Classification:
| Pro Code | Classification Regulation | Classification Name | Device Class | Panel |
|---|---|---|---|---|
| DJG | 862.3650 | Enzyme Immunoassay, Opiate | Class II | 91 |
4
11. Identification of Predicates:
| K-number | Manufacturer | Product | Method |
|---|---|---|---|
| K110298 | Lin-Zhi | ||
| International | Enzyme | ||
| Immunoassay, | |||
| Opiate | Enzyme | ||
| Immunoassay |
12. Device Description
Synermed Opiate Enzyme Immunoassay
The Synermed Opiate Enzyme Immunoassay is ready to use. The composition of the Synermed Opiate Enzyme Immunoassay Reagent is as follows:
Antibody/Substrate Reagent (R1): Contains mouse monoclonal anti-morphine antibody, opiate-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative.
Enzyme-drug Conjugate Reagent (R2): Contains morphine-labeled opiate-6-phosphate dehydrogenase (G6PDH) in buffer with sodium azide (0.09 %) as a preservative.
Intended Use
Synermed Opiate Enzyme Immunoassay
The Synermed Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. This assay is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmatory method such as GCMS or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liguid Chromatography/Mass Spectrometry (GC/MS or LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
13. 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 to detect the amount of absorbance which is proportional to the concentration of the analyte in the specimen.
| Items | |
|---|---|
| Candidate Device: Synermed IR-500 Opiate Enzyme Immunoassay | |
| Predicate Device: Lin-Zhi Opiate Immunoassay |
5
| Similarity/Difference | ||
|---|---|---|
| Intended Use | The Synermed Opiate Enzyme Immunoassay The | |
| Opiate Enzyme Immunoassay from | ||
| Immunoassay, when used in conjunction with | ||
| Synermed IR series analyzers is intended fordetermination of morphine in human | ||
| urine at a cutoff value of 300 ng/mL in urine. | ||
| The assay is designed for professional use. | Same | |
| Analyte | Morphine | Same |
| Specimen | Urine | Same |
| Cutoff | 300 ng/mL | Same |
| Matrix | Urine | Same |
| Storage | 2-8°C until expiration date | Same |
| Calibration/QC | Programmable Cal/OC | 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-500) as compared to the previously cleared Hitachi 717. The sponsor has chosen the representative analyte Opiate using urine as the representative sample matrix.
Analytical Performance
a. Precision/Reproducibility
Verification of semi-quantitative precision on the Synermed IR-500 was accomplished by implementing the study protocol laid out in NCCLS document EP05-A3, Chapter 3. Qualitative verification was accomplished by implementing the study protocol laid out in CLSI EP12-A, Chapter 7. Eleven concentrations of pooled human urine were run for opiate. 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 opiate at each concentration. For qualitative analysis, the results were compared to the expected result (negative expected results should yield negative results in the precision study). Each level of pooled human urine was confirmed by Ultra High-Performance Liquid Chromatography Tandem Mass Spectrometry, for verification chromatography refer to Appendix A: UHPLC-MSMS Raw Data.
6
Table 3 – Semi-Quantitative Opiate Precision Comparison to Lin-Zhi Results (per Package Insert)
| Opiate Tested
Concentrations | IR-500
Within-Run
Expected | Results
Pos/Neg | IR-500
Run-To-Run
Expected | Results
Pos/Neg |
|---------------------------------|----------------------------------|--------------------|----------------------------------|--------------------|
| 0 ng/mL | - | - | - | - |
| 75 ng/mL | - | - | - | - |
| 150 ng/mL | - | - | - | - |
| 225 ng/mL | - | - | - | - |
| 300 ng/mL | + | + | + | + |
| 375 ng/mL | + | + | + | + |
| 450 ng/mL | + | + | + | + |
| 525 ng/mL | + | + | + | + |
| 600 ng/mL | + | + | + | + |
| 800 ng/mL | + | + | + | + |
| 1000 ng/mL | + | + | + | + |
Table 4 – Qualitative Opiate Precision Comparison to Lin-Zhi Results (per Package Insert)
| Opiate Tested
Concentrations | Within-Run
Results
Pos/Neg | Run-to-Run
Results
Pos/Neg | Expected
Result
(Pos/Neg) |
|---------------------------------|----------------------------------|----------------------------------|---------------------------------|
| 0 ng/mL | - | - | - |
| 75 ng/mL | - | - | - |
| 150 ng/mL | - | - | - |
| 225 ng/mL | - | - | - |
| 300 ng/mL | + | + | + |
| 375 ng/mL | + | + | + |
| 450 ng/mL | + | + | + |
| 525 ng/mL | + | + | + |
| 600 ng/mL | + | + | + |
| 800 ng/mL | + | + | + |
| 1000 ng/mL | + | + | + |
7
b. Linearity/Reportable Range
Linearity studies were designed using NCCLS EP06-A. Samples were prepared by intermixing a high urine pool with a low urine pool to obtain ten concentrations across the measuring range with four replicates at each concentration. The observed values were compared to the expected values and are summarized below. Each level of pooled human urine was confirmed by Ultra High-Performance Liquid Chromatography Tandem Mass Spectrometry.
| "Expected" Value
(ng/mL) | Mean Observed Value
(ng/mL) | Recovery
(%) |
|-----------------------------|--------------------------------|-----------------|
| 1250 | 1032.5 | 82.6 |
| 1100 | 907.3 | 82.5 |
| 1000 | 875.0 | 87.5 |
| 800 | 662.0 | 82.8 |
| 600 | 513.8 | 85.6 |
| 450 | 369.5 | 82.1 |
| 300 | 240.5 | 80.2 |
| 225 | 192.3 | 85.4 |
| 150 | 135.0 | 90.0 |
| 75 | 67.3 | 89.7 |
| 25 | 15.5 | 62.0 |
| 0 | 11.0 | #DIV/0! |
| Table 3 - Opiate Analytical Recovery | |||
|---|---|---|---|
8
c. Analytical Specificity
The following endogenous compounds were spiked into urine spiked with morphine to +/- 25% of cutoff (225 and 375 ng/mL). The spiked solutions were evaluated on the IR-500. The substances listed in the following table were determined not to interfere at the concentrations tested.
| Compound | Concentration
ng/mL | -25% Cutoff | | +25% Cutoff | |
|------------------------|------------------------|-------------|----------------|-------------|----------------|
| | | Qual | Semi-
Quant | Qual | Semi-
Quant |
| Acetone | 1000 | Negative | Negative | Positive | Positive |
| Ascorbic Acid | 1500 | Negative | Negative | Positive | Positive |
| Creatinine | 500 | Negative | Negative | Positive | Positive |
| Ethanol | 1000 | Negative | Negative | Positive | Positive |
| Glucose | 3000 | Negative | Negative | Positive | Positive |
| Hemoglobin | 300 | Negative | Negative | Positive | Positive |
| Human Serum
Albumin | 500 | Negative | Negative | Positive | Positive |
| Riboflavin | 0.3 | Negative | Negative | Positive | Positive |
| Sodium
Chloride | 6000 | Negative | Negative | Positive | Positive |
| Urea | 6000 | Negative | Negative | Positive | Positive |
9
d. Comparison Studies
Method comparison was performed according to CLSI EP09-A3, 100 samples for opiate were tested on the IR-500, Hitachi 717 chemistry analyzers, and Ultra High-Performance Liquid Chromatography Tandem Mass Spectrometry (LC-MSMS). The study results are summarized in the table below. Each level of pooled human urine was confirmed by Ultra High-Pressure Liquid Chromatography Tandem Mass Spectrometry, for verification chromatography refer to Appendix A: UHPLC-MSMS Raw Data.
Table 2 - IR-500 Summary of Semi-Quantitative Comparison Data vs LCMS
| Candidate
Device
Results | Negative | Low
Negative
(