ICHEM 100 URINE CHEMISTRY ANALYZER

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k060280 B. Purpose for Submission: Modified 510(k): The sponsor wishes to establish clear ownership of their earlier cleared test system which will now be marketed under a new name. Additionally, the analyzer software was modified since the initial clearance of the product. C. Manufacturer and Instrument Name: Iris Diagnostics facility in Marburg, Germany, iChem 100 Urine Chemistry Analyzer (IRIS is an abbreviation for International Remote Imaging Systems.) D. Type of Test(s) Performed: Qualitative and Semi-quantitative urine chemistry assays E. System Description 1. Device Description: This is a semi-automated benchtop instrument, intended exclusively for use with the sponsors earlier cleared test strips (k030600). Components include a keyboard, transport mechanism, display screen, printer, and barcode reader. Test strips are manually dipped into the urine sample and placed on the instrument transport belt. The strip is transported into the instrument where readings of each chemistry are taken at timed intervals. Readings are converted to concentrations which are displayed to the operator. There are also options to print results or to transmit them to a Laboratory Information System. 2. Principles of Operation: The technology utilized in the instrument is reflectance spectroscopy. The reflectance densitometer reads at three wavelengths; 450, 530, and 625 nm. Instead of using a photodiode detector to measure the reflected light, the instrument utilizes a complementary metal oxide semiconductor (CMOS) image sensor. This technology is {1} well established and is the same as the sponsor’s earlier cleared instrument. 3. **Modes of Operation:** The instrument allows both batch and stat modes. 4. **Specimen Identification:** Specimens are identified by a barcode reader or by manual input via the keyboard. A work list can also be created by the operator. 5. **Specimen Sampling and Handling:** The iChem reagent strip is manually dipped into a urine specimen then placed on the instrument transport belt. All steps that follow are automatically controlled by the instrument’s software. 6. **Calibration:** No external calibration strips or procedures are required. Prior to each measurement the device is calibrated using a one-point optics alignment calibration. If readings fall outside of acceptable limits, a secondary standard is moved into place to perform a two-point calibration. The approach to calibration is appropriate for the CMOS image sensor technology. 7. **Quality Control (QC):** A control file may be set up by the operator to record the lot and expiration of the control material, and to establish the frequency for running controls. The software also allows manual microscopic examination results to be entered into the system. Commercially available control materials (negative and known positive concentrations) are recommended for use according to local, state, and federal regulatory guidelines. Specific controls are not identified. 8. **Software:** FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☑ or No ☐ The following sections are presented in the submission, and they appear adequate: {2} Level of Concern – The sponsor has classified their device as a Moderate Level of Concern. Software Description – An overview of the features controlled by the software and the software operating environment is present. Hazard Analysis – A summary of the Failure Mode and Effects Analysis activity is presented. It lists hardware and software hazards, severity assessments, and mitigations. It identifies the cause(s) of hazards, methods of control (e.g., alarm, hardware design), corrective measures taken, including an explanation of the aspects of the device design/requirements, that eliminate, reduce, or warn of a hazardous event, and verification that the method of control was implemented correctly. Software Requirements Specification (SRS) – A document listing functional requirements for the software, e.g., interface, performance, or functional needs is provided. Architecture Design Chart – A design specification document is provided. Traceability Analysis – Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing is provided. Software Development Environment Description – A summary of the software development life cycle and the processes that are in place to manage the various life cycle activities is provided, e.g., changes or adjustments to software after released into market. Additionally, an annotated list of control documents generated during the development process is present. It includes a summary of the configuration management and maintenance activities. (The waterfall process model of development was used.) Verification and Validation Documentation – A description of V&V activities at the unit, integration, and system level are present. System level test protocols, including pass/fail criteria, and test results are also provided. Revision Level History – The sponsor has provided the Revision history log, including release version number and date. Unresolved Anomalies – The sponsor indicates there are no known unresolved anomalies at the time of this submission. Therefore, a list of remaining software anomalies, annotated with an explanation of the impact on safety or effectiveness, including operator usage and human factors is not needed. F. Regulatory Information: 1. Regulation section: Class II: 21CFR §862.1340 – Urinary glucose (nonquantitative) test system 21CFR §864.6550 – Occult blood test {3} Class I: 21 CFR §862.1095 - Ascorbic acid test system 21 CFR §862.1115 - Urinary bilirubin and its conjugates (nonquantitative) test system. 21 CFR §862.1435 - Ketones (nonquantitative) test system 21 CFR §862.1510 - Nitrite (nonquantitative) test system 21 CFR §862.1550 - Urinary pH (nonquantitative) test system 21 CFR §862.1645 - Urinary protein or albumin (nonquantitative) test system 21 CFR §862.1785 - Urinary urobilinogen (nonquantitative) test system 21 CFR §862.2300 - Colorimeter, photometer, or spectrophotometer for clinical use 21 CFR §864.7675 - Leukocyte peroxidase test 21 CFR §862.2900 - Automated urinalysis system 2. Classification: Class II (blood and glucose) and the remainder are Class I (The class I analyzer is subject to review because Class II analytes are run on it. Class I analytes are reviewed because they are part of a device which includes class II devices.) 3. Product code: Class II: JIL, JIO Class I: JMA, JJB, JIN, JMT, CEN, JIR, CDM, JJQ, LJX, KQO 4. Panel: 75 (Chemistry) G. Intended Use: 1. Indication(s) for use: The iChem100 Urine Chemistry Analyzer (iChem100) is a semi-automated benchtop urine chemistry analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. The iChem100 is intended for use only with iChem 10 SG Urine Chemistry Strips provided by Iris Diagnostics and is intended for use exclusively by healthcare professionals. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders. 2. Special conditions for use statement(s): {4} For professional use. ## H. Substantial Equivalence Information: 1. Predicate device name(s): AUTION JET AJ-4270, IRIS Diagnostics 2. Predicate 510(k) number(s): k030600 3. Comparison with predicate: Both devices measure various chemistry parameters in urine, are semi-automated analyzers, and utilize the same test methodology. The site where the instruments are manufactured are different, however both are manufactured by IRIS Diagnostics, International. ## I. Standard/Guidance Document Referenced (if applicable): The sponsor references the following standards: EN 51010A-1 Safety requirements for electrical equipment, Part 1, General requirements. CAN/CSA-C22.2, No. 1010.1, Safety requirements for electrical equipment, Part 1, General requirements. ## J. Performance Characteristics: 1. Analytical performance: To demonstrate performance of the iChem analyzer the sponsor presents data from two types of studies, as appropriate. (Not all studies are done for each analyte.) a. Accuracy: Results from the iChem100 were compared to those from a commercially available system, the AUTION JET AJ-4270 test system. Ascorbic Acid was compared to the UrinQuic device. Testing was performed by skilled personnel at IRIS. Clinical Urine samples for the study were obtained from a local medical center. The samples include both normal and abnormal levels of urine analytes. Results obtained in these correlation studies are presented in block tables according to the {5} ranges reported by the individual systems. Additionally, values obtained from all urine samples were referred to as either negative (normal) or positive (abnormal) findings. These data are presented in 2X2 tables for comparison of the two assay methods. ## Glucose Correlation Study: Categorized by Reporting Ranges (mg/dL) | | | Arkray Result | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | Neg. | @ 30/50 | @ 70/100 | @ 150/200 | @ 300/500 | @ > 1000 | Total | | iChem Result | Neg. | 156 | 0 | 0 | 0 | 0 | 0 | 156 | | | @ 50 | 2 | 5 | 5 | 0 | 0 | 0 | 12 | | | @ 150 | 0 | 0 | 1 | 3 | 4 | 3 | 11 | | | @ 500 | 0 | 0 | 0 | 0 | 1 | 5 | 6 | | | @ > 1000 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | | | Total | 158 | 5 | 6 | 3 | 5 | 11 | 188 | ## Glucose Correlation Study: Categorized by Negative/Positive Findings | | Arkray Negative | Arkray Positive | Total | | --- | --- | --- | --- | | iChem Negative | 156 | 0 | 156 | | iChem Positive | 2 | 30 | 32 | | Total | 158 | 30 | 188 | ## Blood Correlation Study: Categorized by Reporting Ranges (mg/dL) | | | Arkray Result | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 0 | @ 0.03 | @ 0.06/0.1 | @ 0.2/0.5 | @ 1 | Total | | iChem Results | 0 | 147 | 1 | 2 | 0 | 0 | 150 | | | @ 0.03 | 4 | 12 | 3 | 1 | 0 | 20 | | | @ 0.2 | 0 | 1 | 0 | 3 | 2 | 6 | | | @ 1.0 | 1 | 0 | 0 | 2 | 9 | 12 | | | Total | 152 | 14 | 5 | 6 | 11 | 188 | ## Blood Correlation Study: Categorized by Negative/Positive Findings | | Arkray Negative | Arkray Positive | Total | | --- | --- | --- | --- | | iChem Negative | 147 | 3 | 150 | | iChem Positive | 5 | 33 | 38 | | Total | 152 | 36 | 188 | The following analytes were tested using both spiked samples (compared to expected spiked {6} value) and clinical samples compared to results from a predicate device: ## Ascorbic Acid | iChem 100 | | Spiked Concentration (mg/dL) | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | 0 | 10 | 20 | 30 | 40 | | | 40 | | | 3 | 25 | 40 | | | 20 | | | 60 | 38 | 23 | | | Neg | 63 | 63 | | | | | iChem 100 | | Predicate Device (mg/dL) | | | | --- | --- | --- | --- | --- | | | | Neg | 20 | 40 | | | 40 | | 3 | 1 | | | 20 | 2 | 9 | | | | Neg | 89 | | | ## Bilirubin | iChem 100 | | Spiked Concentration (mg/dL) | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 0 | 0.8 | 1 | 1.5 | 2 | 4 | | | 4 | | | | | | 9 | | | 2 | | | | 22 | 53 | 53 | | | 1 | | | | 30 | 7 | 1 | | | Neg | 63 | 63 | 63 | 27 | 3 | | | iChem 100 | | Predicate Device (mg/dl) | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | 0 | 0.5-1.0 | 2.0 | 6.0-10.0 | >10.0 | | | 4 | 1 | | 3 | | 1 | | | 2 | 8 | 3 | 14 | | | | | 1 | 6 | 7 | | | | | | Neg | 141 | 2 | 2 | | | ## Ketones | iChem 100 | | Spiked Concentration (mg/dL) | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 0 | 20 | 25 | 30 | 100 | 300 | | | 300 | | | | | 2 | 55 | | | 100 | | | | | 59 | 2 | | | 25 | | 42 | 53 | 48 | | | | | Neg | 54 | | | | | | {7} 8 | iChem 100 | | Predicate Device (mg/dL) | | | | | --- | --- | --- | --- | --- | --- | | | | 0 | 5-60 | 80-100 | >150 | | | 300 | | | | | | | 100 | | | | | | | 25 | 4 | 16 | | | | | Neg | 167 | 1 | | | ## Leukocytes | iChem 100 | | Spiked Concentration (WBC/μL) | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 0 | 15 | 25 | 50 | 75 | 500 | | | 500 | | | 11 | 9 | 10 | 57 | | | 75 | | 6 | 29 | 24 | 22 | 6 | | | 25 | | 57 | 26 | 32 | 27 | | | | Neg | 63 | | 1 | | 4 | | | iChem 100 | | Predicate Device (WBC/μL) | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | 0 | 25 | 75 | 250 | 500 | | | 500 | | | 3 | 5 | 11 | | | 75 | | 1 | | | 1 | | | 25 | 17 | 3 | 2 | 1 | | | | Neg | 142 | | 2 | | | ## Nitrite | iChem 100 | | Spiked Concentration (mg/dL) | | | | | --- | --- | --- | --- | --- | --- | | | | 0 | 0.03 | 0.05 | 0.08 | | | Pos | | 32 | 44 | 59 | | | Neg | 57 | 32 | 19 | 4 | | iChem 100 | | Predicate Device (mg/dL) | | | | | --- | --- | --- | --- | --- | --- | | | | 0 | 0.03 | 0.05 | 0.08 | | | Pos | 2 | 31 | | | | | Neg | 154 | 1 | | | ## pH | iChem 100 | | Spiked Concentration (pH meter) | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | 5 | 6 | 7 | 8 | 9 | | | 5.0 | 10 | | | | | | | 6.0 | | 2 | | | | | | 7.0 | | 8 | | | | | | 8.0 | | | 10 | | | | | 9.0 | | | | 10 | 10 | {8} 9 | iChem 100 | | Predicate Device (pH) | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | 5.0-5.5 | 6.0-6.5 | 7.0-7.5 | 8.0-8.5 | 9.0 | | | 9.0 | | | 1 | | 2 | | | 8.0 | | | 8 | | | | | 7.0 | | 15 | 5 | | | | | 6.0 | 10 | 34 | 1 | | | | | 5.0 | 87 | 25 | | | | ## Protein | iChem 100 | | Spiked Concentration (mg/dL) | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 0 | 15 | 30 | 50 | 100 | 500 | | | 500 | | | | | | 42 | | | 100 | | | | 14 | 42 | | | | 30 | | 5 | 42 | 28 | | | | | Neg | 42 | 37 | | | | | | iChem 100 | | Predicate Device (mg/dL) | | | | | --- | --- | --- | --- | --- | --- | | | | 0 | 10-70 | 100-200 | 300-600 | | | 500 | | | | 3 | | | 100 | | 2 | 15 | 2 | | | 30 | 13 | 37 | 1 | | | | Neg | 112 | 2 | 1 | | ## Specific Gravity | iChem 100 | | Spiked Concentration (refractometer) | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 | 1.035 | | | 1.000 | 10 | | | | | | | | | | 1.005 | | 10 | 8 | | | | | | | | 1.010 | | | 2 | 2 | | | | | | | 1.015 | | | | 8 | 2 | | | | | | 1.020 | | | | | 8 | 1 | | | | | 1.025 | | | | | | 9 | 3 | | | | 1.030 | | | | | | | 7 | 10 | | | 1.035 | | | | | | | | | {9} 10 | iChem 100 | | Predicate Device (Sp. Grav.) | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 | >1.030 | | | 1.035 | | | | | | | 3 | 1 | | | 1.030 | | | | | | 1 | 9 | 9 | | | 1.025 | | 1 | | | 3 | 5 | 13 | 9 | | | 1.020 | | | | | 8 | 14 | 3 | 5 | | | 1.015 | | | | 1 | 16 | 8 | 1 | | | | 1.010 | | | 1 | 12 | 12 | | | | | | 1.005 | | 15 | 8 | 9 | 5 | 2 | | | | | 1.000 | | 3 | | | | | | | ## Urobilinogen | iChem 100 | | Spiked Concentration (mg/dL) | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 0 | 1 | 2 | 3 | 4 | 8 | 12 | | | 12 | | | | | | | | | | 8 | | | | 57 | 56 | 57 | 58 | | | 4 | | 5 | 24 | 1 | 3 | | | | | 2 | | 52 | 9 | | 1 | | | | | Neg | 63 | 23 | 1 | | | | | | iChem 100 | | Predicate Device (mg/dL) | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | 0 | 2-3 | 4-6 | 8-12 | >12 | | | 12 | | | | | 1 | | | 8 | 1 | 2 | 3 | 1 | | | | 4 | | 4 | | | | | | 2 | 12 | 5 | | | | | | Neg | 157 | 2 | | | | ## Color Since the predicate device and the subject device differ in the number of colors for reporting results (16 for the predicate and 10 for the subject device), the sponsor compared the color on the two devices in 629 clinical samples: {10} 11 | iChem 100 | | Predicate Device (color) | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | Colorless | Light Yellow | Yellow/Dark Yellow | Light Orange/Orange/Dark Orange | Light Red/Red/Dark Red | Light Brown/Brown/Dark Brown | Green | Violet/Blue | | | Black | | | | | | 1 | | | | | Green | | | | | | | | | | | Brown | | | | | | | | | | | Red Brown | | | | | | 1 | | | | | Red | | | 18 | | 6 | | | | | | Orange | | | 2 | 1 | | 3 | | | | | Amber | 4 | 2 | 111 | 2 | 11 | 8 | | | | | Yellow | 52 | 72 | 305 | 4 | 1 | | | | | | Straw | 12 | 4 | 6 | | | | | | | | Colorless | | | 3 | | | | | | b. Precision/Reproducibility: Two levels of commercially available control (normal and abnormal concentrations of each analyte) were analyzed to estimate precision of the test system. Testing was performed in the sponsor's own laboratory by their employees. To estimate total imprecision, 23 abnormal samples and 20 normal samples were run over a 13 day period. To estimate within-run imprecision 20 normal and 20 abnormal samples were analyzed in a single run. Testing was performed on the candidate device, and the candidate device prior to the software modifications. Testing was done in the sponsor's laboratory by trained laboratory technicians. Total Precision, Candidate Device at Normal Levels | Analyte | Control Range | % Reflectance | Standard deviation | % CV | 95% Confidence Interval for CV | | --- | --- | --- | --- | --- | --- | | Bilirubin | Neg | 63.6 | 2.1 | 3.3 | [2.6-4.7] | | Urobilinogen | Norm | 57.7 | 1.9 | 3.3 | [2.6-4.7] | | Ketones | Neg | 57.9 | 2.3 | 4.0 | [3.1-5.6] | | Ascorbic Acid | 20-40 mg/dL | 56.2 | 1.2 | 2.1 | [1.6-3.0] | | Protein | Neg | 61.9 | 1.2 | 1.9 | [1.5-2.7] | {11} | Analyte | Control Range | % Reflectance | Standard deviation | % CV | 95% Confidence Interval for CV | | --- | --- | --- | --- | --- | --- | | PH | 5-9 | 66.6 | 1.0 | 1.5 | [1.2-2.1] | | Nitrite | Neg | 65.1 | 2.1 | 3.3 | [2.5-4.6] | | Leukocyte | Neg | 62.5 | 1.9 | 3.0 | [2.4-4.3] | | Specific Gravity | 1.000-1.035 | 27.9 | 1.3 | 4.5 | [3.6-6.6] | | Blood | Neg | 65.4 | 0.8 | 1.2 | [0.9-1.7] | | Glucose | Neg | 78.9 | 1.4 | 1.8 | [1.4-2.5] | Total Precision, Candidate Device at Abnormal Levels | Analyte | Control Range | % Reflectance | Standard deviation | % CV | 95% Confidence Interval for CV | | --- | --- | --- | --- | --- | --- | | Bilirubin | 1-4 mg/dL | 28.5 | 2.5 | 8.8 | [6.8-12.5] | | Urobilinogen | 2-12 mg/dL | 38.2 | 1.9 | 5.0 | [3.8-7.0] | | Ketones | 25-300 mg/dL | 7.5 | 0.7 | 9.3 | [7.2-13.3] | | Ascorbic Acid | Neg | 7.9 | 0.7 | 8.9 | [6.8-12.6] | | Protein | 30 - ≥500 mg/dL | 29.0 | 0.9 | 3.1 | [2.4-4.4] | | PH | 5-9 | 39.8 | 1.3 | 3.3 | [2.5-4.6] | | Nitrite | Pos | 46.4 | 1.5 | 3.2 | [2.5-4.6] | | Leukocyte | 25-500 WBC’s/uL | 54.3 | 1.3 | 2.4 | [1.8-3.4] | | Specific Gravity | 1.000-1.035 | 19.8 | 1.5 | 7.6 | [5.8-10.8] | | Blood | 0.03-1 mg/dl | 4.1 | 0.1 | 2.4 | [1.9-3.4] | | Glucose | 50-≥1000/mg/dL | 20.8 | 1.3 | 6.2 | [4.8-8.9] | Within-Run Precision, Candidate Device at Normal Levels | Analyte | Control Range | % Reflectance | Standard deviation | % CV | 95% Confidence Interval for CV | | --- | --- | --- | --- | --- | --- | | Bilirubin | Neg | 65.1 | 1.7 | 2.6 | [2.0-3.8] | | Urobilinogen | Norm | 59.9 | 1.4 | 2.3 | [1.8-3.4] | | Ketones | Neg | 60.6 | 1.5 | 2.5 | [1.9-3.6] | | Ascorbic Acid | 20-40 | 55.4 | 0.7 | 1.3 | [1.0-1.8] | {12} | Analyte | Control Range | % Reflectance | Standard deviation | % CV | 95% Confidence Interval for CV | | --- | --- | --- | --- | --- | --- | | | mg/dL | | | | | | Protein | Neg | 60.7 | 0.4 | 0.66 | [0.5-1.0] | | PH | 5-9 | 65.4 | 1.0 | 1.5 | [1.2-2.2] | | Nitrite | Neg | 67.8 | 1.8 | 2.6 | [2.0-3.9] | | Leukocyte | Neg | 64.8 | 1.2 | 1.8 | [1.4-2.7] | | Specific Gravity | 1.000-1.035 | 26.1 | 0.8 | 3.1 | [2.3-4.5] | | Blood | Neg | 65.0 | 0.6 | 0.9 | [0.7-1.3] | | Glucose | Neg | 79.0 | 1.4 | 1.8 | [1.3-2.6] | Within-Run Precision, Candidate Device at Abnormal Levels | Analyte | Control Range | % Reflectance | Standard deviation | % CV | 95% Confidence Interval for CV | | --- | --- | --- | --- | --- | --- | | Bilirubin | 1-4 mg/dL | 30.5 | 1.7 | 5.6 | [4.2-8.2] | | Urobilinogen | 2-12 mg/dL | 40.2 | 1.8 | 4.5 | [3.4-6.5] | | Ketones | 25-300 mg/dL | 8.8 | 0.5 | 5.7 | [4.3-8.3] | | Ascorbic Acid | Neg | 8.1 | 0.3 | 3.7 | [2.8-5.4] | | Protein | 30 - ≥500 mg/dL | 29.0 | 0.4 | 1.4 | [1.0-2.0] | | PH | 5-9 | 38.6 | 1.2 | 3.1 | [2.4-4.5] | | Nitrite | Pos | 47.9 | 1.2 | 2.5 | [1.9-3.7] | | Leukocyte | 25-500 WBC’s/uL | 55.5 | 0.8 | 1.4 | [1.1-2.1] | | Specific Gravity | 1.000-1.035 | 21.1 | 1.4 | 6.6 | [5.0-9.7] | | Blood | 0.03—1 mg/dl | 3.8 | 0.1 | 2.6 | [2.0-3.8] | | Glucose | 50-≥1000/mg/dL | 20.1 | 1.5 | 7.4 | [5.7-10.9] | # c. Linearity/assay reportable range: Analyte free urine was fortified with glucose or hemoglobin to various concentrations spanning the reportable range of the assay. Results appear linear. The discrete reporting levels for glucose are 0, 50, 150, 500, and $\geq 1000\mathrm{mg / dL}$ of glucose. Glucose Linearity Study Results {13} | Known Analyte Concentration (mg/dL) | Observed Result (mg/dL) | | --- | --- | | 1500 | ≥ 1000 | | 1000 | ≥ 1000 | | 500 | 500 | | 400 | 500 | | 200 | 150 | | 100 | 150 | | 50 | 50 | | 30 | 50 | | 0 | 0 | Discrete reporting levels for blood are 0, 0.03, 0.2, and 1.0 mg/dL hemoglobin. Hemoglobin Linearity Study Results | Known Analyte Concentration (mg/dL) | Observed Result | | --- | --- | | 1.0 | 1.0 | | 0.9 | 1.0 | | 0.5 | 1.0 | | 0.1 | 0.2 | | 0.03 | 0.03 | | 0 | 0 | See the method comparison section above for performance of spiked samples with the other analytes. d. Carryover: There are no apparent carryover issues with this test system/ instrument. Strips are unitized devices. They are manually dipped, with excess liquid being removed. Strips are then placed in a horizontal position for analysis. There is little chance for run over, and no problems were observed during studies. e. Interfering Substances: Because test strips have not been changed, and only minor modifications have been made to the instrument which should not affect performance, these studies were not repeated. 2. Other Supportive Instrument Performance Data Not Covered Above: {14} Instrument maintenance is minimal, i.e., wiping the outside of the instrument and transporter belt, and emptying the waste container. **K. Proposed Labeling:** The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10. **L. Conclusion:** The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 15