(148 days)
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.
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.
The provided text describes the performance summary of the VITROS Chemistry Products Cl- Slides, a device for quantitatively measuring chloride (Cl-) concentration in serum, plasma, and urine. It does not contain information about an AI-powered device or an MRMC comparative effectiveness study. Therefore, sections related to AI, expert involvement, and MRMC studies cannot be filled from this document.
Here's a summary of the acceptance criteria and study detailed in the document for the VITROS Chemistry Products Cl- Slides:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria / Study Method | Reported Device Performance |
|---|---|---|
| Method Comparison | CLSI Protocol EP09-A3 (Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 2013). Comparison against Siemens Chloride (CL) method for ADVIA® Chemistry Systems. | VITROS CI Slides = 0.996 x [Siemens] - 4.7 mmol/L with a correlation coefficient (r) of 0.998. This demonstrates excellent correlation with the predicate device. |
| Precision | CLSI Protocol EP05-A3 (Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition). Pooled estimates of two reagent lots. Two runs per day for 20 nonconsecutive days, with four precision samples in duplicate per run. | Within-Day CV%: 0.4% - 3.3% Within-Lab CV%: 0.6% - 4.2% (across different mean concentrations: 18, 105, 191, 282 mmol/L). These CV% values are very low, indicating high precision of the device across the measuring range. |
| Limit of Blank (LoB) | CLSI EP17-A2 (Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures). | 1.1 mmol/L. |
| Limit of Detection (LoD) | CLSI EP17-A2 (Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures). Proportions of false positives (α) and false negatives (β) less than 5%; based on 180 determinations, with 4 blank and 6 low-level samples. | 2.2 mmol/L. |
| Limit of Quantitation (LoQ) | CLSI EP17-A2 (Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures). Imprecision within 5%. | 5 mmol/L. |
| Linearity | CLSI EP06-A (Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline). Evaluation across one slide lot on one VITROS 5,1 FS Chemistry System using a commercial linearity panel. | Linear Regression Equation: Y = 1.0044x - 1.37 with a Correlation Coefficient, R2 = 0.9995. This indicates excellent linearity across the determined range of 12 to 320 mmol/L, supporting the proposed measuring range. |
| Measuring Range | Determined by assessing LoQ and linearity results from three slide lots and limited by the predicate method's lower range (15 mmol/L). | 15 to 300 mmol/L for urine. |
| Expected Values (Random Urine) | CLSI EP28-A3c (Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition). Evaluation of 135 normal patient samples using two slide lots on one VITROS 5,1 FS Chemistry System. | 17 to 209 mmol/L. |
| Expected Values (24-hour Urine) | Based on a literature reference. | 110 - 250 mmol/day (from Wu, Alan H.B. Tietz Clinical Guide to Laboratory Tests. 4th ed. Saunders Elsevier, St. Louis, MO: 2006, 234-241). |
| Interfering Substances | CLSI Protocol EP07-A2 (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition). Acceptance criterion for bias was not explicitly stated but implied by "bias < 5%" for non-interfering substances. | Known Interferences: Bromide and iodide from therapeutic drugs and ointments (positive bias). Specimens Not Recommended: Urine with Hydrochloric acid (12N HCl) or 10% Thymol in isopropanol preservatives. Substances that Do Not Interfere: Numerous common substances (e.g., Acetaminophen, Ascorbic Acid, Bilirubin, Ibuprofen) at specified concentrations, with observed bias < 5%. pH (4-9) and Specific Gravity (1.00-1.04) also found not to interfere. |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison: 130 human urine samples were tested. 125 of these samples were within the measuring range of both the VITROS CT assay and the Siemens Chloride assay. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it refers to "human urine samples" and "patient samples" which typically implies clinical samples.
- Precision: Four precision samples were used, two commercially available control materials in a human urine matrix, and two prepared in a polyvinylpyrrolidone (PVP) matrix. Each sample was run in duplicate, two runs per day, for 20 nonconsecutive days. This totals 80 observations per sample type (4 samples * 2 replicates * 2 runs * 20 days / 4 samples = 80 observations (No. Observ. in table is for each sample)).
- Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ): Based on 180 determinations, with 4 blank and 6 low-level samples.
- Linearity: A commercial urine linearity panel was used, consisting of 5 additional levels prepared from admixtures of high and low pools, and an additional four levels targeting lower chloride concentrations, for a total of 11 levels.
- Expected Values (Random Urine): An "in-house collection of 135 normal patient samples" was evaluated.
- Interfering Substances: The study involved testing various substances at specified concentrations; the exact number of unique samples or tests for this section is not precisely quantified, but it's implied by the long list of tested substances and their concentrations.
Data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin. "Human urine samples" and "normal patient samples" suggest clinical origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes an in vitro diagnostic device that measures chloride levels. The "ground truth" for such devices is typically established through reference methods or established assays, not through expert consensus on medical images or clinical observations. Therefore, there is no information provided about experts or their qualifications for establishing ground truth in the context of this device.
4. Adjudication Method for the Test Set
Not applicable. The device performs a quantitative chemical measurement. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or subjective assessments, such as in image interpretation studies, where human readers might disagree.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes an in vitro diagnostic device for chemical analysis, not an AI-powered diagnostic tool for human readers. There is no mention of human readers, AI assistance, or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device, the VITROS Chemistry Products Cl- Slides, is a standalone in vitro diagnostic assay that performs quantitative measurements of chloride. It operates independently of human interpretation in its primary function of providing a numerical chloride concentration. The provided performance data (method comparison, precision, linearity, etc.) inherently reflect its standalone performance.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is based on:
- Reference methods/predicate devices: For method comparison, the Siemens ADVIA® Chloride (CL) assay was used as the predicate (gold standard).
- Known concentrations: For precision, linearity, LoB/LoD/LoQ studies, materials with known or carefully characterized chloride concentrations (commercial controls, prepared panels, blank samples, low-level samples) were used.
- Literature references: For 24-hour urine expected values, a published medical textbook was referenced.
- Normal patient samples: For random urine expected values, a collection of normal patient samples was used to define the reference interval, presumably with their chloride levels being the "ground truth" for what is considered normal.
8. The Sample Size for the Training Set
This document describes the validation of an in vitro diagnostic assay, not a machine learning or AI model. Therefore, the concept of a "training set" in the context of AI is not applicable. The studies described are for validation of the device's performance characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI sense for this type of device. The ground truth for the various performance studies (as described in point 7) was established through reference methods, known concentrations, and literature.
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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.
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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
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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) |
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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 marketeddevice to whichequivalence is claimed | The VITROS Chemistry Products Cl⁺ slides are substantiallyequivalent to the Siemens ADVIA® Chloride (CL) assay,cleared on May 21, 1999 (K990346). |
| Device description | The VITROS® Chemistry Products Cl⁺ Slide assay isperformed using the VITROS® Chemistry Products Cl⁺ Slideand the VITROS® Chemistry Products Calibrator Kit 2 onthe VITROS Chemistry Systems.The VITROS® Cl- Slide is a multilayered, analytical elementcoated on a polyester support that uses direct potentiometryfor measurement of chloride ions. All reactions necessary fora single quantitative measurement of chloride take placewithin 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, asilver layer and a silver chloride layer coated on a polyester support |
| support. The protective layer inhibits interference fromnormal levels of bromide and uric acid. | |
| Indications For Use | Rx. For in vitro diagnostic use only .VITROS® ChemistryProducts Cl⁻ Slides quantitatively measure chloride (Cl⁻)concentration in serum, plasma, and urine using VITROS®Chemistry Systems. Chloride measurements are used in thediagnosis and treatment of electrolyte and metabolicdisorders such as cystic fibrosis and diabetic acidosis. |
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| Characteristic | Predicate DeviceSiemens ADVIA Chloride(CL) assay (K990346) | New/Modified DeviceVITROS ChemistryProducts Cl- Slides |
|---|---|---|
| Indications for Use | For in vitro diagnostic use inthe quantitative determinationof chloride in human serum,plasma and urine on theADVIA Chemistry systems. | Rx. For in vitro diagnostic useonly .VITROS® ChemistryProducts Cl- Slidesquantitatively measurechloride (Cl-) concentration inserum, plasma, and urine usingVITROS® Chemistry Systems.Chloride measurements areused in the diagnosis andtreatment of electrolyte andmetabolic disorders such ascystic fibrosis and diabeticacidosis. |
| 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 Rangefor Urine | 15-400 mmol/L | 15-300 mmol/L |
| Expected Valuesfor 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.
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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.
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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
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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 < 5%.
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| Substance Tested | Highest Concentration with noSignificant Interference | |
|---|---|---|
| Conventional Units | SI Units | |
| Acetaminophen | 50 mg/dL | 3.31 mmol/L |
| Allopurinol | 24 mg/dL | 1.8 mmol/L |
| Amiloride HCl | 1.5 mg/dL | 56 µmol/L |
| Ascorbic Acid | 180 mg/dL | 10 mmol/L |
| Bilirubin, conjugated | 7.25 mg/dL | 91 µmol/L |
| Boric Acid | 670 mg/dL | 108 mmol/L |
| Boric Acid + Sodium Formate | 670 mg/dL +335 mg/dL | 108 mmol/L + 49mmol/L |
| Carbenicillin Disodium | 300 mg/dL | 7.1 mmol/L |
| Ciprofloxacin | 1.16 mg/dL | 35 µmol/L |
| Furosemide | 9 mg/dL | 0.27 mmol/L |
| Gentamicin Sulfate | 1.5 mg/dL | 10 µmol/L |
| Glacial Acetic Acid | 10 mL/L | 175 mmol/L |
| Glutathione | 1.0 mg/dL | 33 µmol/L |
| Hemoglobin | 1000 mg/dL | 0.16 mmol/L |
| Ibuprofen | 50 mg/dL | 2.42 mmol/L |
| Intralipid | 2524 mg/dL | 2.524 g/L |
| Levodopa | 67 mg/dL | 3.4 mmol/L |
| Lithium Carbonate | 236.5 mg/dL | 29.6 mmol/L |
| Mannitol | 60 mg/dL | 3.3 mmol/L |
| N-Acetyl Cysteine | 166.2 mg/dL | 10 mmol/L |
| Ofloxacin | 32 mg/dL | 0.89 mmol/L |
| pH | 4 - 9 | N/A |
| Penicillin G | 59.7 mg/dL | 1.7 mmol/L |
| Phenazopyridine HCl | 19.5 mg/dL | 0.91 mmol/L |
| Prednisone | 230 µg/dL | 6.4 µmol/L |
| Ranitidine HCl | 670 µg/dL | 19 µmol/L |
| Sodium Cefoxitin | 340 mg/dL | 7.57 mmol/L |
| Sodium Fluoride | 500 mg/dL | 119 mmol/L |
| Sodium Formate | 335 mg/dL | 49 mmol/L |
| Sodium Oxalate | 60 mg/dL | 4.5 mmol/L |
| Specific Gravity* | 1.00 - 1.04 | N/A |
| Tetracycline HCl | 70 mg/dL | 1.58 mmol/L |
| Toluene | 1.3 mL/L | 12 mmol/L |
- Specific gravity was evaluated using three patient samples with chloride concentrations of 50 -67 mmol/L
Conclusion:
The conclusions drawn from the nonclinical tests (discussed above) demonstrate the VITROS Chemistry Products CI Slides are as safe, effective, and perform as well as the predicate device. The information submitted in the premarket notification is complete and supports a substantial equivalence decision.
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References
-
- CLSI. Measurement Procedure Comparison and Bias Estimate Using Patient Samples; Approved Guideline - Third Edition. CLSI document EP09-A3-IR [ISBN 1-56238-887-81. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2013.
-
- Evaluation of Precision of Ouantitative Measurement Procedures; Approved Guideline - Third Edition. CLSI document EP05-A3 [ISBN 1-56238-968-8]. CLSI, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2014.
-
- CLSI. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition. CLSI document EP17-A2 (IBSN 1-56238-796-0). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500. Wayne Pennsylvania 19087 USA. 2012.
-
- CLSI. Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI document EP06-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2003.
-
- CLSI. Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI document EP28-A3c [ISBN 1-56238-682-4]. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2010.
-
- Wu, Alan H.B. Tietz, Clinical Guide to Laboratory Tests. 4th ed. Saunders Elsevier, St. Louis, MO: 2006, 234-241.
-
- Clinical and Laboratory Standards Institute (CLSI). Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition, CLSI document EP07-A2 (ISBN 1-56238-584-4), Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2005.
§ 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.