(64 days)
Not Found
No
The summary describes standard in-vitro diagnostic reagents and their performance characteristics, with no mention of AI or ML.
No
The device is described as being used for in-vitro diagnostic purposes to quantitate levels of electrolytes, which is for diagnosis and monitoring, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Synermed ISE Reagents are used for in-vitro diagnostic use to quantitate levels of Sodium, Potassium and Chloride in serum." It also mentions their use in the "diagnosis and treatment" of various diseases.
No
The device description clearly states the device is a set of chemical reagents, which are physical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagents are "used for in-vitro diagnostic use to quantitate levels of Sodium, Potassium and Chloride in serum." It also mentions their use in the diagnosis and treatment of various diseases.
- Device Description: The description details the chemical composition of the reagents, which are used to perform tests on biological samples (serum).
- Performance Studies: The document describes performance studies (Precision, Linearity, Analytical Specificity, Comparison Studies) that are typical for evaluating the performance of an IVD device.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K952179) indicates that this device is being compared to a previously cleared IVD device.
All of these factors clearly point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Synermed ISE Reagents are used for in-vitro diagnostic use to quantitate levels of Sodium, Potassium and Chloride in serum. This device is for use in clinical laboratories only. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Product codes
JGS, CGZ, CEM
Device Description
The Synermed ISE reagents contain the following ingredients: Sodium Chloride, Potassium Chloride, Sodium Bicarbonate, Potassium Phosphate. The ISE buffer contains trlethanolamine preservatives 0.1M, phosphoric acid 0.3% and nonreactive preservatives. The ISE Mid-Standard contains sodium chloride 2.96mM, potassium chloride 0.12M, buffer and non-reactive preservatives. The ISE Reference contains 1M potassium chloride.
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 only.
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
Precision/Reproducibility: Testing for Precision was accomplished by following the procedures and protocols outlined in the CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition, and in NCCLS EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline - Second Edition. Precision data was analyzed per NCCLS document EP15-A2; Section 8 pp. 6-10. Acceptance criteria: The Within-Run Precision and Within-Laboratory Precision results should be less than the noted requirements from Westgard for percent imprecision. All results Passed (Y).
Linearity/Reportable Range: Testing for Linearity and Random Error was accomplished by following the procedures and protocols outlined in the NCCLS document EP6-A, Vol. 23, No. 16; Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach: Approved Guideline. QC samples were performed before daily testing AND with each run. QC results must be within the established range before testing can begin. The stated sample range tested and claimed measuring range for Sodium is 80-180 mmol/L, Potassium is 1.5-10 mmol/L, and Chloride is 60-140 mmol/L.
Analytical Specificity (Interfering Substances): Testing for Interference was accomplished by following the procedures and protocols outlined in the CLSI document EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; Second Edition. The following concentrations of endogenous substances were shown not to interfere with Sodium and Chloride: Hemoglobin-500mg/dL, Bilirubin (conjugated and unconjugated)-342umol/L, Triglycerides-37mmol/L. The following concentrations of endogenous substances were shown not to interfere with Potassium: Bilirubin (conjugated and unconjugated)-342umol/L, Triglycerides-37mmol/L. Acceptance Criteria: Analyte Target Concentration
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 10, 2018
Infrared Laboratory Systems, LLC (dba Synermed) Julie Paschal Regulatory Affairs Specialist 17408 Tiller Court Suite 1900 Westfield. IN 40674
Re: K181201
Trade/Device Name: Synermed ISE Reagents Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CGZ, CEM Dated: February 27, 2018 Received: May 11, 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
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 comprehensive regulatory information about mediation-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) K181201
Device Name Synermed ISE Reagents
Indications for Use (Describe)
The Synermed ISE Reagents are used for in-vitro diagnostic use to quantitate levels of Sodium, Potassium and Chloride in serum. This device is for use in clinical laboratories only. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
| 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
K181201
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
3. Date Prepared: July 2, 2018
4. Device Trade Name: Synermed ISE Reagents
5. Reagent Device Classification:
| Pro
Code | Classification
Regulation | Classification Name | Device Class | Panel |
|-------------|------------------------------|-----------------------|--------------|-------|
| JGS | 862.1665 | Sodium test system | Class II | 75 |
| CEM | 862.1600 | Potassium test system | Class II | 75 |
| CGZ | 862.1170 | Chloride test system | Class II | 75 |
6. Identification of Predicates:
| K-number | Manufacturer | Trade Name | Method |
|---|---|---|---|
| K952179 | Synermed | Synermed | |
| ISE | |||
| Reagents | Ion Selective | ||
| Electrode |
7. Device Description
The Synermed ISE reagents contain the following ingredients: Sodium Chloride, Potassium Chloride, Sodium Bicarbonate, Potassium Phosphate. The ISE buffer contains trlethanolamine preservatives 0.1M, phosphoric acid 0.3% and nonreactive preservatives. The ISE Mid-Standard contains sodium chloride 2.96mM, potassium chloride 0.12M, buffer and non-reactive preservatives. The ISE Reference contains 1M potassium chloride.
4
8. Substantial Equivalence
| Items | Candidate Device: | Predicate Device: |
|---|---|---|
| Synermed ISE Reagents | ||
| K181201 | Synermed ISE Reagents | |
| K952179 | ||
| Similarities | ||
| Intended Use | Quantitative Measurement | |
| of Sodium, Potassium and | ||
| Chloride in serum | Same | |
| Environment | Clinical Laboratory Use | |
| Only | Same | |
| Specimen | Serum | Same |
| Differences | ||
| For use with | Synermed IR-1200 | Hitachi 717 |
9. Intended Use
ISE Reagents
The Synermed ISE reagents are intended for the in vitro quantitative measurement of sodium, potassium, and chloride in serum. This device is for use in clinical laboratories only. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
10. Summary of Performance Testing
a. Precision/Reproducibility
Testing for Precision was accomplished by following the procedures and protocols outlined in the CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition, and in NCCLS EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline - Second Edition
Results: Data Examination - NCCLS document EP15-A2; Section 8 pp. 6-10.
Precision Data Analysis Section Figure 1.1 - Mean, Standard Deviation & %CV for all 80 Results for Sodium
5
| Target
Concentration
of Sodium in
mEq/L | Actual
Mean
in
mEq/L | Westgard
%CV Within
Run
Requirement | Within
Run
%CV | Within
Run
SD | %CV
Pass
(Y/N) | Westgard
%CV Run to
Run
Requirement | Run to
Run
%CV | Run to
Run
SD | %CV
Pass
(Y/N) |
|--------------------------------------------------|-------------------------------|----------------------------------------------|----------------------|---------------------|----------------------|----------------------------------------------|----------------------|---------------------|----------------------|
| 81 | 81.1 | | 0.05 | 0.04 | Y | | 0.04 | 0.03 | Y |
| 115 | 114.87 | | 0.06 | 0.07 | Y | | 0.05 | 0.06 | Y |
| 135 | 134.97 | 0.6 | 0.05 | 0.06 | Y | 0.7 | 0.04 | 0.06 | Y |
| 150 | 150.02 | | 0.06 | 0.09 | Y | | 0.05 | 0.07 | Y |
| 180 | 181.05 | | 0.07 | 0.13 | Y | | 0.07 | 0.12 | Y |
Figure 1.2 - Mean, Standard Deviation & %CV for all 80 Results for Potassium
| Potassium Precision Data Summary Table | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Target | |||||||||
| Concentration | |||||||||
| of Potassium | |||||||||
| in mEq/L | Actual | ||||||||
| Mean | |||||||||
| in | |||||||||
| mEq/L | Westgard | ||||||||
| %CV Within | |||||||||
| Run | |||||||||
| Requirement | Within | ||||||||
| Run | |||||||||
| %CV | Within | ||||||||
| Run | |||||||||
| SD | %CV | ||||||||
| Pass | |||||||||
| (Y/N) | Westgard | ||||||||
| %CV Run to | |||||||||
| Run | |||||||||
| Requirement | Run to | ||||||||
| Run | |||||||||
| %CV | Run to | ||||||||
| Run | |||||||||
| SD | %CV | ||||||||
| Pass | |||||||||
| (Y/N) | |||||||||
| 1.5 | 1.49 | 0.52 | 0.01 | Y | 0.37 | 0.01 | Y | ||
| 3.0 | 2.98 | 0.22 | 0.01 | Y | 0.19 | 0.01 | Y | ||
| 5.8 | 5.79 | 4.6 | 0.12 | 0.01 | Y | 5.6 | 0.1 | 0.01 | Y |
| 7.5 | 7.49 | 0.11 | 0.01 | Y | 0.09 | 0.01 | Y | ||
| 10.0 | 10.04 | 0.58 | 0.06 | Y | 0.46 | 0.05 | Y |
Figure 1.3 - Mean, Standard Deviation & %CV for all 80 Results for Chloride
| Chloride Precision Data Summary Table | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Target | |||||||||
| Concentration | |||||||||
| of Chloride in | |||||||||
| mEq/L | Actual | ||||||||
| Mean | |||||||||
| in | |||||||||
| mEq/L | Westgard | ||||||||
| %CV Within | |||||||||
| Run | |||||||||
| Requirement | Within | ||||||||
| Run | |||||||||
| %CV | Within | ||||||||
| Run | |||||||||
| SD | %CV | ||||||||
| Pass | |||||||||
| (Y/N) | Westgard | ||||||||
| %CV Run to | |||||||||
| Run | |||||||||
| Requirement | Run to | ||||||||
| Run | |||||||||
| %CV | Run to | ||||||||
| Run | |||||||||
| SD | %CV | ||||||||
| Pass | |||||||||
| (Y/N) | |||||||||
| 60 | 60.22 | 0.52 | 0.31 | Y | 0.48 | 0.29 | Y | ||
| 90 | 90.08 | 0.1 | 0.09 | Y | 0.07 | 0.07 | Y | ||
| 101 | 100.77 | 1.2 | 0.48 | 0.49 | Y | 1.5 | 0.43 | 0.43 | Y |
| 112 | 112 | 0.08 | 0.09 | Y | 0.06 | 0.06 | Y | ||
| 130 | 129.98 | 0.06 | 0.08 | Y | 0.05 | 0.48 | Y |
Acceptance Criteria
- The Within-Run Precision and Within-Laboratory Precision results should be less than ● the noted requirements from Westgard for percent imprecision.
6
b. Linearity/Reportable Range
Linearity
Testing for Linearity and Random Error was accomplished by following the procedures and protocols outlined in the NCCLS document EP6-A, Vol. 23, No. 16; Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach: Approved Guideline
QC samples will be performed before daily testing AND with each run. QC results must be within the established range before testing can begin.
| Measurand (in
mmol/L) | Slope | Intercept | R2 | Sample Range
Tested (in
mmol/L) | Claimed Measuring
Range (in mmol/L) |
|--------------------------|--------|-----------|--------|---------------------------------------|----------------------------------------|
| Sodium | 0.9987 | 1.1021 | 0.9995 | 80-180 | 80-180 |
| Potassium | 1.0048 | 0.0237 | 0.9999 | 1.5-10 | 1.5-10 |
| Chloride | 0.9814 | 1.3911 | 0.9998 | 60-140 | 60-140 |
Linearity Results:
c. Analytical Specificity
Interfering Substances
Testing for Interference was accomplished by following the procedures and protocols outlined in the CLSI document EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; Second Edition.
The following concentrations of endogenous substances were shown not to interfere with Sodium and Chloride. Hemoglobin- 500mg/dL Bilirubin (conjugated and unconjugated)- 342umol/L Triglycerides- 37mmol/L
The following concentrations of endogenous substances were shown not to interfere with Potassium. Bilirubin (conjugated and unconjugated)- 342umol/L Triglycerides- 37mmol/L
Acceptance Criteria - Analyte Target Concentration ≤ ± 10% bias.
No bias was seen to be greater than 10%, thus all potential endogenous substance interference is considered to be within acceptable range. Hemolysis is a known contributing factor to abnormally high potassium levels, therefore hemolyzed samples should not be used. Other exogenous substances studies will be referenced to studies done by Young, et al.
7
d. Comparison Studies
Testing for Comparisons and Bias was accomplished by following the procedures and protocols outlined in the CLSI document EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition.
Data Examination
- a. Visual examination of the data is performed to look for outliers.
- b. A correlation coefficient was calculated for each analyte.
- c. Slope and Intercept were also calculated for each analyte.
Table 2.1 - IR-1200 and Hitachi 717 Comparison Study Data Summary
| Sodium | |
|---|---|
| Correlation Coefficient | 0.992246 |
| Slope | 0.990656 |
| Intercept | 0.943789 |
| Potassium | |
| Correlation Coefficient | 0.993021 |
| Slope | 0.985861 |
| Intercept | -0.10291 |
| Chloride | |
| Correlation Coefficient | 0.993346 |
| Slope | 0.998305 |
| Intercept | 0.122558 |
11. Conclusions
The new device is substantially equivalent to the predicate because it has the same intended use and has the same or similar technological characteristics that do not raise new types of questions of safety and effectiveness.