(148 days)
Not Found
No
The summary describes a chemical assay using ion-selective electrodes and standard clinical chemistry performance studies. There is no mention of AI or ML.
No
This device is for in vitro diagnostic use only, specifically for quantitatively measuring chloride concentration in bodily fluids to diagnose and treat electrolyte and metabolic disorders. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and "Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis." This directly indicates its role in diagnosing medical conditions.
No
The device description explicitly states it is a "multilayered, analytical element coated on a polyester support" and uses "two ion- selective electrodes," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Purpose: The device is intended to "quantitatively measure chloride (Cl⁻) concentration in serum, plasma, and urine." This is a measurement performed on biological samples outside of the body.
- Clinical Use: The measurements are used "in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis." This indicates a clinical purpose for the results obtained from the device.
- Device Description: The description details a "multilayered, analytical element" and "ion-selective electrodes" which are components designed for analyzing chemical properties of a sample.
- Performance Studies: The document describes performance studies like "Method Comparison," "Precision," "Linearity," and "Interfering Substances," which are standard evaluations for IVD devices to demonstrate their accuracy and reliability for clinical use.
- Predicate Device: The mention of a "Predicate Device(s)" (K990346; Siemens ADVIA® Chloride (CL) assay) is common in regulatory submissions for IVDs, indicating a comparison to an already cleared device of the same type.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Rx. For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma, and urine using VITROS Chemistry and Integrated Systems. Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Product codes
CGZ
Device Description
The VITROS® Chemistry Products Cl⁺ Slide assay is performed using the VITROS® Chemistry Products Cl⁺ Slide and the VITROS® Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS® Cl- Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of chloride ions. All reactions necessary for a single quantitative measurement of chloride take place within the multi-layered analytical element of a VITROS® Chemistry Products Cl⁺ slide. The slide consists of two ion-selective electrodes, each containing a protective layer, a silver layer and a silver chloride layer coated on a polyester support. The protective layer inhibits interference from normal levels of bromide and uric acid.
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
A total of 130 human urine samples were tested for Method Comparison. The 130 samples were measured with VITROS CT Slides and a predicate method, Siemens Chloride (CL) method for ADVIA® Chemistry Systems. Of the 130 samples tested 125 were within the measuring range of both the VITROS CT assay (15-300 mmol/L) and the Siemens Chloride assay (15 - 400 mmol/L).
For Precision evaluation: Two of the evaluation samples were commercially available control materials in a human urine matrix, and two samples were prepared in a polyvinylpyrrolidone (PVP) matrix to challenge the ends of the proposed measuring range. Data generated for the reported claims are pooled estimates of two reagent lots. Precision results for each slide lot were evaluated independently, but data from two lots were pooled per the procedure described in CLSI EP05-A32.
For Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ): 180 determinations, with 4 blank and 6 low-level samples.
For Linearity: A commercial urine linearity panel was used to evaluate linearity of the VITROS CI Slides for urine. The low pool had an estimated concentration near 0 mmol/L. The high pool had an estimated concentration of 320 mmol/L. The commercial panel contained 5 additional levels prepared from admixtures of the high and low pools. An additional four levels targeting lower chloride concentrations were prepared from the intermediate levels for a total of 11 levels.
For Measuring Range and Expected Results: An in-house collection of 135 normal patient samples were evaluated using two slide lots on one VITROS 5,1 FS Chemistry System.
For Interfering Substances: The VITROS Chemistry Products CI Slides assay was screened for interfering substances. The substances listed in the table were tested with the VITROS Cli Slides for urine at chloride concentrations of approximately 20 and 180 mmol/L. Specific gravity was evaluated using three patient samples with chloride concentrations of 50 -67 mmol/L.
Summary of Performance Studies
Substantial Equivalence was demonstrated by testing several performance characteristics including method comparison, precision, detection limits, linearity, measuring range, expected values, and interfering substances.
Method Comparison:
- Study Type: Followed CLSI Protocol EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples (2013).
- Sample Size: 130 human urine samples.
- Key Results: The relationship between the VITROS CI Slides method and the Predicate method (Siemens Chloride) based on data from 125 samples using slide lot 4005-0626-9198 on the VITROS 5,1 FS Chemistry System is: VITROS CI Slides = 0.996 x [Siemens] - 4.7 mmol/L with a correlation coefficient (r) of 0.998.
Precision:
- Study Type: Evaluation performed according to CLSI protocol EP05-A: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition.
- Sample Size: Data generated for the reported claims are pooled estimates of two reagent lots. Two runs were performed on each of 20 nonconsecutive days. Each run consisted of four precision samples run in duplicate.
- Key Results:
- 5,1 FS System Mean (mmol/L): 18, SD 0.2 (Repeatability), SD 0.6 (Within-Day), SD 0.8 (Within Lab).
- 5,1 FS System Mean (mmol/L): 105, SD 0.5 (Repeatability), SD 0.5 (Within-Day), SD 0.7 (Within Lab).
- 5,1 FS System Mean (mmol/L): 191, SD 0.6 (Repeatability), SD 0.7 (Within-Day), SD 1.2 (Within Lab).
- 5,1 FS System Mean (mmol/L): 282, SD 0.9 (Repeatability), SD 1.1 (Within-Day), SD 2.6 (Within Lab).
Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ):
- Study Type: Determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures.
- Sample Size: Based on 180 determinations, with 4 blank and 6 low-level samples.
- Key Results: LoB = 1.1 mmol/L, LoD = 2.2 mmol/L, LoQ = 5 mmol/L. Proportions of false positives (α) and false negatives (β) were less than 5%.
Linearity:
- Study Type: Evaluation performed following CLSI EP06-A. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline.
- Sample Size: Not explicitly stated beyond "one slide lot on one VITROS 5,1 FS Chemistry System" and a commercial urine linearity panel with 11 levels.
- Key Results: The assay is linear across the determined range of 12 to 320 mmol/L, which supports the proposed measuring range of 15 to 300 mmol/L. Linear Regression Equation: Y = 1.0044x - 1.37, Correlation Coefficient, R2 = 0.9995.
Measuring Range and Expected Results:
- Study Type: Expected values were established per CLSI EP28-A3c. Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition.
- Sample Size: 135 normal patient samples.
- Key Results: The measuring range for the VITROS CT Slides assay for urine is 15 to 300 mmol/L. The expected values for random urine are 17 to 209 mmol/L. The expected value for 24 hour urine samples, 110- 250 mmol/day, was based on a literature reference.
Interfering Substances:
- Study Type: Screened following CLSI Protocol EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition.
- Key Results:
- Specimens Not Recommended: Urine with Hydrochloric acid (12N HCl) or 10% Thymol in isopropanol.
- Known Interferences: Bromide and iodide from therapeutic drugs and ointments may cause a positive bias of approximately 5 mmol/L and 6 mmol/L, respectively, for each mmol of halide.
- Substances that Do Not Interfere: Numerous substances listed in a table were tested at chloride concentrations of approximately 20 and 180 mmol/L and found not to interfere (bias
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles facing right, connected by flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 16, 2016
ORTHO CLINICAL DIAGNOSTICS MARLENE HANNA SR. MANAGER REGULATORY AFFAIRS 100 INDIGO CREEK DRIVE ROCHESTER, NY 14626
Re: K162020
Trade/Device Name: VITROS Chemistry Products Cl- Slides Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride test system Regulatory Class: II Product Code: CGZ Dated: November 9, 2016 Received: November 10, 2016
Dear Marlene Hanna:
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.
Courtney H. Lias -S
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) K162020
Device Name VITROS Chemistry Products Cl- Slides
Rx. For in vitro diagnostic use only.
VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma, and urine using VITROS Chemistry and Integrated Systems. Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
3
510(k) Summary: K162020
VITROS Chemistry Products Cl- Slides: A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter Information | |
|---|---|
| Name | Ortho-Clinical Diagnostics, Inc. |
| Address | 100 Indigo Creek Drive |
| Rochester, New York 14626 | |
| Phone number | 585-453-4041 |
| Fax number | 585-453-3368 |
| Marlene.hanna@orthoclinicaldiagnostics.com | |
| Establishment Registration | 1319809 |
| Name of contact person | Marlene Hanna , RAC |
| Date prepared | December 12, 2016 |
| Name of devices | |
| Trade or proprietary name | VITROS Chemistry Products Cl⁺ Slides |
| Common or usual name | Chloride test |
| Classification name | Chloride test system |
| Classification panel | Chemistry |
| Regulation | 21 CFR 862.1170 |
| Product Code(s) | CGZ |
| Legally marketed | |
| device to which | |
| equivalence is claimed | The VITROS Chemistry Products Cl⁺ slides are substantially |
| equivalent to the Siemens ADVIA® Chloride (CL) assay, | |
| cleared on May 21, 1999 (K990346). | |
| Device description | The VITROS® Chemistry Products Cl⁺ Slide assay is |
| performed using the VITROS® Chemistry Products Cl⁺ Slide | |
| and the VITROS® Chemistry Products Calibrator Kit 2 on | |
| the VITROS Chemistry Systems. | |
| The VITROS® Cl- Slide is a multilayered, analytical element | |
| coated on a polyester support that uses direct potentiometry | |
| for measurement of chloride ions. All reactions necessary for | |
| a single quantitative measurement of chloride take place | |
| within the multi-layered analytical element of a VITROS® | |
| Chemistry Products Cl⁺ slide. The slide consists of two ion- | |
| selective electrodes, each containing a protective layer, a | |
| silver layer and a silver chloride layer coated on a polyester support | |
| support. The protective layer inhibits interference from | |
| normal levels of bromide and uric acid. | |
| Indications For Use | Rx. For in vitro diagnostic use only .VITROS® Chemistry |
| Products Cl⁻ Slides quantitatively measure chloride (Cl⁻) | |
| concentration in serum, plasma, and urine using VITROS® | |
| Chemistry Systems. Chloride measurements are used in the | |
| diagnosis and treatment of electrolyte and metabolic | |
| disorders such as cystic fibrosis and diabetic acidosis. |
4
| Characteristic | Predicate Device
Siemens ADVIA Chloride
(CL) assay (K990346) | New/Modified Device
VITROS Chemistry
Products Cl- Slides |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | For in vitro diagnostic use in
the quantitative determination
of chloride in human serum,
plasma and urine on the
ADVIA Chemistry systems. | Rx. For in vitro diagnostic use
only .VITROS® Chemistry
Products Cl- Slides
quantitatively measure
chloride (Cl-) concentration in
serum, plasma, and urine using
VITROS® Chemistry Systems.
Chloride measurements are
used in the diagnosis and
treatment of electrolyte and
metabolic disorders such as
cystic fibrosis and diabetic
acidosis. |
| Sample Types | Serum, Plasma, Urine | Same |
| Reaction type | Potentiometric | Same |
| Method Principle | Ion Selective Electrode (ISE),
Indirect (diluted) | Ion Selective Electrode (ISE),
Direct (undiluted) |
| Measuring Range
for Urine | 15-400 mmol/L | 15-300 mmol/L |
| Expected Values
for Urine | 110 – 250* mmol/day | Same |
Comparison with Predicate Device:
*Wu, Alan H.B. Tietz Clinical Guide to Laboratory Tests. 4th ed. Saunders Elsevier, St. Louis, MO: 2006, 234-241.
5
Performance Summary:
Substantial Equivalence was demonstrated by testing several performance characteristics including method comparison, precision, detection limits, linearity, measuring range, expected values, and interfering substances.
Method Comparison:
Method Comparison testing followed CLSI Protocol EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples (2013)'. A total of 130 human urine samples were tested. The 130 samples were measured with VITROS CT Slides and a predicate method, Siemens Chloride (CL) method for ADVIA® Chemistry Systems. Of the 130 samples tested 125 were within the measuring range of both the VITROS CT assay (15-300 mmol/L) and the Siemens Chloride assay (15 - 400 mmol/L).
The relationship between the VITROS CI Slides method and the Predicate method (Siemens Chloride) based on data from 125 samples using slide lot 4005-0626-9198 on the VITROS 5,1 FS Chemistry System is as follows:
VITROS CI Slides = 0.996 x [Siemens] - 4.7 mmol/L with a correlation coefficient (r) of 0.998.
Precision:
The evaluation was performed according to CLSI protocol EP05-A: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition 2 . The data generated for the reported claims are pooled estimates of two reagent lots. Precision results for each slide lot were evaluated independently, but data from two lots were pooled per the procedure described in CLSI EP05-A32. Two runs were performed on each of 20 nonconsecutive days. Each run consisted of four precision samples run in duplicate. Two of the evaluation samples were commercially available control materials in a human urine matrix, and two samples were prepared in a polyvinylpyrrolidone (PVP) matrix to challenge the ends of the proposed measuring range. Runs within day were separated by at least two hours. A fresh sample aliquot was used for each run. Data were screened for gross outliers according to the statistical outlier test in CLSI EP05-A3- . No outlier data points were observed.
Precision for VITROS CI Slides for use with Urine
| Conventional and SI Units (mmol/L) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | Repeatability | Within-Day | Within Lab | No. | No. | ||||
| System | (mmol/L) | SD | CV% | SD | CV%* | SD | CV%** | Observ. | Days |
| 5,1 FS | 18 | 0.2 | 1.2 | 0.6 | 3.3 | 0.8 | 4.2 | 80 | 20 |
| 5,1 FS | 105 | 0.5 | 0.4 | 0.5 | 0.5 | 0.7 | 0.6 | 80 | 20 |
| 5,1 FS | 191 | 0.6 | 0.3 | 0.7 | 0.4 | 1.2 | 0.6 | 80 | 20 |
| 5,1 FS | 282 | 0.9 | 0.3 | 1.1 | 0.4 | 2.6 | 0.9 | 80 | 20 |
Within Day precision was determined using two runs per day with two replications.
** Within Lab precision was determined using a single lot of slides and calibrating weekly.
6
Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ):
The Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantitation (LOQ) of the VITROS CI assay were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures'. The following limits were determined:
| LoB*
(mmol/L) | LoD**
(mmol/L) | LoQ***
(mmol/L) |
|------------------|-------------------|--------------------|
| 1.1 | 2.2 | 5 |
- Limit of Blank, or the highest value likely to be observed with a sample containing no analyte, replaces the term "analytical sensitivity."
** Proportions of false positives (α) and false negatives (β) were less than 5%; based on 180 determinations, with 4 blank and 6 low-level samples.
*** The level of imprecision used to accept the LoQ was within 5%
Linearity:
The linearity evaluation was performed following CLSI EP06-A. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline , across one slide lot on one VITROS 5,1 FS Chemistry System. A commercial urine linearity panel was used to evaluate linearity of the VITROS CI Slides for urine. The low pool had an estimated concentration near 0 mmol/L. The high pool had an estimated concentration of 320 mmol/L. The commercial panel contained 5 additional levels prepared from admixtures of the high and low pools. An additional four levels targeting lower chloride concentrations were prepared from the intermediate levels for a total of 11 levels. Analysis by linear regression indicated that the assay is linear across the determined range of 12 to 320 mmol/L, which supports the proposed measuring range of 15 to 300 mmol/L.
Results of linearity study:
| Linear Regression Equation | Correlation Coefficient, R2 |
|---|---|
| Y = 1.0044x - 1.37 | 0.9995 |
Measuring Range and Expected Results:
The measuring range of the VITROS CI Slides assay for urine was determined by assessing the limit of quantitation and linearity results obtained from three slide lots, and was limited by the lower measuring range of the predicate method, 15 mmol/L. The measuring range for the VITROS CT Slides assay for urine is 15 to 300 mmol/L. The expected values for random urine samples were established for VITROS CI Slides per CLSI EP28-A3c. Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition'. An in-house collection of 135 normal patient samples were evaluated using two slide
7
lots on one VITROS 5,1 FS Chemistry System. The expected values for random urine are 17 to 209 mmol/L.
The expected value for 24 hour urine samples, 110- 250 mmol/day, was based on a literature reference, Wu, Alan H.B. Tietz Clinical Guide to Laboratory Tests. 4th ed. Saunders Elsevier, St. Louis, MO: 2006, 234-241°.
Interfering Substances:
The VITROS Chemistry Products CI Slides assay was screened for interfering substances following CLSI Protocol EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition' .
Specimens Not Recommended
Urine with the following preservatives:
- Hydrochloric acid (12N HCl) o
- o 10% Thymol in isopropanol
Known Interferences
Bromide and iodide from therapeutic drugs and ointments may cause a positive bias of approximately 5 mmol/L and 6 mmol/L, respectively, for each mmol of halide. Normal physiological levels of bromide and iodide do not interfere.
Interference claims were cited when the observed bias exceeded the acceptance criteria for bias. Substances exhibiting bias less than the stated acceptance criteria have been cited as substances that do not interfere. It is possible that other interfering substances may be encountered. These results are representative; however results may differ somewhat due to test-to-test variation. The degree of interference at concentrations other than those listed may not be predictable.
Specificity
Substances that Do Not Interfere
The substances listed in the table below were tested with the VITROS Cli Slides for urine according to CLSI Protocol EP07-A2', and found not to interfere at the test concentrations shown. The substances were tested at chloride concentrations of approximately 20 and 180 mmol/L and found not to interfere, bias