(84 days)
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No
The device uses a standard photometric method to measure hemoglobin concentration and does not mention any AI/ML components in its description or performance studies.
No
The device is an in vitro diagnostic (IVD) device used for quantitative determination of hemoglobin concentration, which is a diagnostic function, not a therapeutic one.
Yes
This device is for the quantitative determination of hemoglobin concentration, and its intended use explicitly states "The hemochroma PLUS System is for in vitro diagnostic only," which directly indicates it is a diagnostic device.
No
The device description clearly states that the hemochroma PLUS Analyzer is a "battery powered, hand-held device" that uses a "dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer." This indicates the presence of physical hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states, "The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood... The hemochroma PLUS System is for in vitro diagnostic only." This directly indicates its use for testing biological samples outside of the body to diagnose or monitor a condition.
- Device Description: The description details how the device measures hemoglobin concentration in whole blood samples using a photo-absorption method. This process involves analyzing a biological sample (blood) in a laboratory or point-of-care setting.
- Components: The system includes single-use microcuvettes, which are designed to hold the blood sample for analysis. This is a common characteristic of IVD devices.
- Performance Studies: The document describes various performance studies (repeatability, reproducibility, linearity, detection limit, analytical specificity, method comparison, matrix comparison, anticoagulant comparison) that are typical for validating the performance of an IVD device.
The entire context of the document, from the intended use to the description of the testing process and performance studies, clearly points to the hemochroma PLUS System being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K2-EDTA, sodium citrate, lithium heparin, or sodium heparin). The testing system is designed for point-of-care settings, hospitals, and medical lab facilities.
Estimation of hematocrit, as a function, is only for normal hemoglobin values, 12.0 to 180 g/dL) and in patients ≥ 6 months old.
The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration.
The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. The hemochroma PLUS System is for in vitro diagnostic only.
The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglobin concentration in terms of g/dL.
Product codes (comma separated list FDA assigned to the subject device)
GKR, GGM
Device Description
The hemochroma PLUS Analyzer is a battery powered, hand-held device to measure the concentration of total hemoglobin in blood in 3 seconds with 15uL of whole blood. Whole blood may be collected by fingerstick (capillary) or venipuncture and analyzed without preprocessing. The hemochroma PLUS Analyzer uses hemochroma PLUS Microcuvettes with dual ports where the user applies samples either through capillary action or direct volume pipetting.
The hemochroma PLUS Analyzer determines hemoglobin concentration in whole blood samples using a dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and permits photometric determination of hemoglobin in undiluted blood samples. The computed end result is displayed on the LCD display and can be printed on an external printer (optional).
The hemochroma PLUS System consists of a hemochroma PLUS Analyzer, single-use hemochroma PLUS Microcuvettes, hemochroma PLUS ID Chip, optical System Check Microcuvette and hemochroma PLUS Controls.
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hemochroma PLUS Microcuvette
The hemochroma PLUS Microcuvettes are specially designed for use with the hemochroma PLUS Analyzer. The microcuvettes function as measuring devices specifically holding 15 uL of blood and are inserted into the hemochroma PLUS Analyzer. -
hemochroma PLUS ID Chip
The hemochroma PLUS ID chip contains encoded memory with the calibration data/information. With the ID chip inserted in the designated port, the hemochroma PLUS Analyzer reads and utilizes the calibration data regarding the lot under consideration and applies appropriate correction to the conversion formula while computing the test result. -
hemochroma PLUS Optical System Check Microcuvette
hemochroma PLUS Optical System Check Microcuvette is designed for use with the hemochroma PLUS Analyzer only. The Optical System Check Microcuvette is a special glass filter used to measure the degree of light absorption with the spectrophotometric method. If the result is between 11.7-12.3 g/dL, the optic system is working properly according to specification. -
hemochroma PLUS Controls
The hemochromaPLUS Controls: Level 1 (Low), Level 2 (Middle), and Level 3 (High), are external quality controls designed for use with hemochroma PLUS Analyzer only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
≥ 6 months old
Intended User / Care Setting
point-of-care settings, hospitals, and medical lab facilities
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical performance:
Precision/Reproducibility (Repeatability):
Repeatability was assessed in-house using three hemochroma PLUS Microcuvette test lots, three hemochroma PLUS Analyzers, three operators and one lot of hemochroma PLUS Controls (low, middle, and high hemoglobin). Five test samples collected in K2EDTA tubes with hemoglobin concentrations evenly distributed throughout the lower and upper limits and medical decision levels of the analytical measuring range of the hemochroma PLUS Analyzer were tested. Each hemochroma PLUS Analyzer was tested seven times in duplicate (duplicate runs in the morning and duplicate runs in the evening) for a total of 84 tests results for each hemoglobin concentration. Sample Level 1 (5.6 g/dL) and Sample Level 5 (23.7 g/dL) were prepared by spiking natural human whole blood samples. Sample Levels 2 (11.3 g/dL), 3 (14.6 g/dL), and 4 (18.4 g/dL) were sourced from unmodified natural samples. Repeatability results were within the defined acceptance criteria.
Additional repeatability studies were accessed in-house:
- Between Operator: Three operators conducted the testing with five hemoglobin levels of test samples using the same lot of the hemochroma PLUS Microcuvette and the same instrument. Each operator repeated the test seven times in duplicate runs.
- Between Lot: One operator conducted the testing with five hemoglobin levels of test samples using three different lots of hemochroma PLUS Microcuvette and the same instrument. Each Microcuvette lot was tested seven times in duplicate runs.
- Between Instrument: One operator conducted the testing with five hemoglobin levels of test samples using one lot of hemochroma PLUS Microcuvette and three different hemochroma PLUS instruments.
Reproducibility:
Reproducibility was conducted at three intended use sites over 20 operating days utilizing three hemochroma PLUS Microcuvette lots (one lot per site), three hemochroma PLUS Analyzers (one instrument per site), and one lot of hemochroma PLUS Controls (low, middle, and high hemoglobin) tested across the three intended use sites. Testing was done twice daily using the same set of controls, for 20 days. Each control set was run, in duplicate (two runs in the morning and 2 runs in the afternoon), independently, by two operators at each site. A total of 160 test results were generated for each control level at each site. Reproducibility results at all test sites were within the defined acceptance criteria.
Linearity/assay reportable range:
The linearity study was conducted using low and high-level hemoglobin concentrations prepared from a venous blood sample. A total of eleven hemoglobin concentration levels (2.5, 4.8, 7.1, 9.4, 11.7, 14.1, 16.4, 18.7, 21.0, 23.3, and 25.6) spanning the claimed measuring range of the hemochroma PLUS Analyzer (5.0-25.6 g/dL) were tested in triplicate and analyzed using one hemochroma PLUS Analyzer and one lot of hemochroma PLUS Microcuvettes. The hemochroma PLUS Controls (low, middle, and high) were tested to ensure and confirm the validity of the test results obtained with the hemochroma PLUS Analyzer. The mean result for each concentration was plotted against the expected value. Linear regression was performed and based on the data analysis, the hemochroma PLUS System demonstrated linearity over the claimed measuring range of 5.0-25.6 g/dL.
Traceability, Stability, Expected values (controls, calibrators, or methods):
hemochroma PLUS Controls (low, middle, and high) Value Assignment:
Each control level was tested in 15 replicates using the same lot of hemochroma PLUS Microcuvettes on the hemochroma PLUS Analyzer. The percent difference between the expected value and the mean value of the 15 replicates was calculated. The average of the 15 replicates was set as the mean value: 8.5 g/dL (low control), 12.5 g/dL (middle control), and 16.2 g/dL (high control).
Value assignment was conducted using three hemochroma PLUS Analyzers with three lots of hemochroma PLUS Microcuvettes and one lot of each control level. Each control level was tested in 10 replicates on each hemochroma PLUS Analyzer. All data points for the hemochroma PLUS Analyzers were within the acceptance criteria.
Quality Control Stability:
- Closed Vial Stability: Determined by using three lots of hemochroma PLUS Controls (low, middle, and high) stored at refrigerated temperature (2-8°C) and tested one day every month in triplicate for 10 months. Supports a stability claim of 6 months when stored at 2-8°C.
- Open Vial Stability: Determined by using three lots of hemochroma PLUS Controls (low, middle, and high) stored once opened at (2-8°C). Tested every day in triplicate for 17 days. Supports a stability claim of 14 days after opening when stored at 2-8°C after each use.
hemochroma PLUS Microcuvettes Stability:
- Shelf Life Stability: Determined by using three lots of hemochroma PLUS Microcuvettes stored at 15–35°C. Testing was performed one day per month in triplicate for 27 months. Supports a shelf life stability claim of 24 months when stored at 15-35°C.
- Open Container (in-use) Stability: Determined by using three lots of hemochroma PLUS Microcuvettes stored at 15-35°C. Testing was performed one day per month in triplicate for 27 months. Supports a stability claim of 24 months when stored at 15-35°C after the seal is broken.
Sample Stability:
Assessed using one lot of hemochroma PLUS Microcuvettes and one hemochroma PLUS Analyzer. Thirty-seven fresh venous blood samples were collected in K2EDTA tubes and measured immediately. Samples were then stored in the refrigerator (2-8℃) and tested at various time intervals (3, 6, 12 hours, and 1, 2, 3, 6, 7 days). Supports a stability claim of 24 hours when stored at 2-8°C.
Detection limit:
- Limit of Blank (LoB): Five blank hemoglobin depleted human plasma samples measured in five replicates tested over 3 days with three different lots of hemochroma PLUS Microcuvettes and three hemochroma PLUS Analyzers (total of 75 test results per lot). LoB was found to be 0.23 g/dL.
- LoD: Six Hgb-low samples prepared by spiking plasma with red blood cells. Five replicates of each tested over 3 days with three different microcuvette lots using one analyzer (total of 90 test results per lot). LoD was found to be 1.66 g/dL.
- Limit of Quantitation (LoQ): Six low Hgb samples prepared by spiking plasma with red blood cells. Each sample tested in five replicates over 3 days with three different microcuvette lots using one analyzer (total of 90 test results per lot). LoQ was determined to be 4.5 g/dL.
Analytical specificity:
An interference study was conducted to evaluate the potential of various endogenous and exogenous substances. Three hemoglobin levels of human whole blood samples were spiked with various potential interfering substances. Control samples (no interfering substances) and test samples (with interfering substances) were tested in five replicates. All tested interference substances showed non-significant interference up to the concentrations given in the table provided.
Method comparison with predicate device:
Method comparison study was performed at three point-of-care clinical sites in the United States to assess the performance of the hemochroma PLUS System compared to the predicate device (HemoCue Hb 301 System) utilizing a total of 60 capillary finger-stick blood samples and 60 venous blood samples in K2EDTA tubes. An additional 10 hemoglobin samples in extreme hemoglobin ranges were spiked for venous blood samples. Testing was performed using three hemochroma PLUS Analyzers (one at each site), three operators (one at each site), and three lots of the hemochroma PLUS Microcuvettes (one at each site). Linear regression analyses demonstrate comparable performance between hemochroma PLUS System and HemoCue Hb 301 System across the analytical measuring range. The method comparison study demonstrated that the analytical performance of the hemochroma PLUS System test is substantially equivalent to the predicate device.
Matrix comparison:
A matrix comparison study was performed to demonstrate comparability between venous whole blood samples and capillary whole blood samples using the hemochroma PLUS Analyzer. The matrix comparison was performed using whole blood (venous and capillary) from 80 study participants with one hemochroma PLUS Microcuvette lot and one hemochroma PLUS Analyzer. Percent difference between capillary blood and venous blood (K2EDTA) was calculated. A Bland-Altman plot was used to analyze the agreement. The results met the acceptance criteria.
Comparison of hemochroma PLUS Analyzer and HemoCue Hb 301 Analyzer for Disease Conditions:
A study was conducted to determine the hemochroma PLUS Analyzer and HemoCue Hb 301 Analyzer performance when testing certain disease conditions. Venous blood specimens were collected from diseased donors: 3 specimens from donors with Polycythemia, 2 specimens from the donors with hypochromia, 3 specimens from the donors with high WBC count, and 2 specimens from sickle cell donors. Each test specimen was tested 5 times with the HemoCue Hb 301 Analyzer and 5 times with the hemochroma PLUS Analyzer. These results indicate that hemochroma PLUS System hemoglobin assay meets the expected performance criteria therefore, no interference was observed in these disease conditions.
Anticoagulant Comparison (K2EDTA vs K3EDTA, Lithium Heparin, Sodium Heparin, and Sodium Citrate):
Venous blood was collected in each of 2.0 mL anticoagulant tubes (K2EDTA, Lithium Heparin, Sodium Heparin, and Sodium Citrate) from 50 study participants. Spiked plasma samples were used for hemoglobin concentrations in the extreme hemoglobin (low and high) measuring ranges. The % difference between K2EDTA and 4 different anticoagulants was calculated. A Bland-Altman plot was used to analyze the agreement. The results were within the defined acceptance criteria.
Cleaning Disinfection and Robustness Testing:
The hemochroma PLUS Analyzer lifespan claim is 27375 cleaning cycles which is equivalent to 3 years of analyzer life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HemoCue Hb 301 System K061047
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5620 Automated hemoglobin system.
(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 16, 2018
Immunostics, Inc. Junghee Kim Regulatory Affairs Specialist 38 Industrial Way East. Suite1 Eatontown, New Jersey 07724
Re: K182298
Trade/Device Name: hemochroma PLUS System Regulation Number: 21 CFR 864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: Class II Product Code: GKR, GGM Dated: August 22, 2018 Received: August 24, 2018
Dear Junghee Kim:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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,
Leonthena R. Carrington -S
Lea Carrington Director Division of Immunology and Hematology 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) K182298
Device Name hemochroma PLUS System
Indications for Use (Describe)
The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K2-EDTA, sodium citrate, lithium heparin, or sodium heparin). The testing system is designed for point-of-care settings, hospitals, and medical lab facilities.
Estimation of hematocrit, as a function, is only for normal hemoglobin values, 12.0 to 180 g/dL) and in patients ≥ 6 months old.
The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration.
The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. The hemochroma PLUS System is for in vitro diagnostic only.
The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglobin concentration in terms of g/dL.
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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Section 8: 510(k) Summary
hemochroma PLUS System
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR, Section 807.92.
Sponsor's Information
Boditech Med. Inc. 43, Geodudanji 1-Gil, Dongnae-Myeon Chuncheon-si Gangwon-do, 24398 Republic of Korea Phone No .: +82 33-243-1400 Fax No.: +82 33-243-9373 Contact: Hyung-Ju Oh, General Manager of QA/RA E-mail: ohj@boditech.co.kr Website: www.boditech.co.kr Establishment Registration Number: 3009491259
Regulatory Correspondent
Immunostics, Inc. 38 Industrial Way East, Ste.1 Eatontown, NJ 07724 Phone No .: (732) 918-0770 Fax No.: (732) 918-0618 Contact: Junghee Kim, RA Specialist E-mail: jhkim@immunostics.com Website: www.immunostics.com Establishment Registration Number: 2244821
Device Information
Trade/Device Name: hemochroma PLUS System, hemochroma PLUS Controls Regulation Number: 21 CFR § 864.5620, 21 CFR § 864.8625 510(k) Number: K182298 Classification Name: Automated hemoglobin system, Hematology quality control mixture Regulatory Class: Class II Panel: Hematology Product Code: GKR, GGM Predicate Device: HemoCue Hb 301 System Predicate 510(k) Number: K061047
Image /page/3/Picture/10 description: The image shows the logo for Immunostics, Inc. The logo features a stylized sunburst design in pink, followed by the company name "immunostics, inc." in gray, sans-serif font. Two small pink circles are positioned above the "i" and "n" in "inc."
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Intended use(s):
The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K2-EDTA, K3-EDTA, sodium citrate, lithium heparin). The testing system is designed for point-of-care settings, hospitals, and medical lab facilities.
Estimation of hematocrit, as a function, is only for normal hemoglobin values, 12.0 to 18.0 g/dL (120 to 180 g/dL) and in patients ≥ 6 months old.
The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration.
The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. The hemochroma PLUS System is for in vitro diagnostic only.
The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglobin concentration in terms of g/dL.
Device Description:
The hemochroma PLUS Analyzer is a battery powered, hand-held device to measure the concentration of total hemoglobin in blood in 3 seconds with 15uL of whole blood. Whole blood may be collected by fingerstick (capillary) or venipuncture and analyzed without preprocessing. The hemochroma PLUS Analyzer uses hemochroma PLUS Microcuvettes with dual ports where the user applies samples either through capillary action or direct volume pipetting.
The hemochroma PLUS Analyzer determines hemoglobin concentration in whole blood samples using a dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer. The optical distance between the hemochroma PLUS 3 Microcuvette walls is fixed and permits photometric determination of hemoglobin in undiluted blood samples. The computed end result is displayed on the LCD display and can be printed on an external printer (optional).
The hemochroma PLUS System consists of a hemochroma PLUS Analyzer, single-use hemochroma PLUS Microcuvettes, hemochroma PLUS ID Chip, optical System Check Microcuvette and hemochroma PLUS Controls.
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- hemochroma PLUS Microcuvette
Image /page/4/Picture/12 description: The image shows the logo for Immunostics, Inc. The logo features a stylized sunburst symbol in pink, followed by the company name in gray, sans-serif font. Two small pink circles are positioned above the "nostics" portion of the name.
- hemochroma PLUS Microcuvette
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The hemochroma PLUS Microcuvettes are specially designed for use with the hemochroma PLUS Analyzer. The microcuvettes function as measuring devices specifically holding 15 uL of blood and are inserted into the hemochroma PLUS Analyzer.
- hemochroma PLUS ID Chip
The hemochroma PLUS ID chip contains encoded memory with the calibration data/information. With the ID chip inserted in the designated port, the hemochroma PLUS Analyzer reads and utilizes the calibration data regarding the lot under consideration and applies appropriate correction to the conversion formula while computing the test result.
- hemochroma PLUS Optical System Check Microcuvette
hemochroma PLUS Optical System Check Microcuvette is designed for use with the hemochroma PLUS Analyzer only. The Optical System Check Microcuvette is a special glass filter used to measure the degree of light absorption with the spectrophotometric method. If the result is between 11.7-12.3 g/dL, the optic system is working properly according to specification.
- hemochroma PLUS Controls
The hemochromaPLUS Controls: Level 1 (Low), Level 2 (Middle), and Level 3 (High), are external quality controls designed for use with hemochroma PLUS Analyzer only.
Substantial Equivalence Information:
Predicate 510(k) number(s): K061047
| Similarities | ||
|---|---|---|
| Item | Device | |
| hemochroma PLUS System | ||
| K182298 | Predicate | |
| HemoCue Hb 301 System | ||
| K061047 | ||
| Intended | ||
| Use/Indications for | ||
| Use | The hemochroma PLUS System is | |
| for the quantitative determination | ||
| of hemoglobin concentration in | ||
| non-anticoagulated capillary | ||
| (finger-stick) whole blood or | ||
| venous whole blood (K2-EDTA, | ||
| K3-EDTA, sodium citrate, lithium | The HemoCue Hb 301 System is | |
| designed for quantitative point- | ||
| ofcare whole blood hemoglobin | ||
| determination in primary care using | ||
| a specially designed analyzer, the | ||
| HemoCue Hb 301 Analyzer, and | ||
| specially designed microcuvettes, | ||
| the HemoCue Hb 301 | ||
| Parameter(s) | ||
| heparin, or sodium heparin). The | ||
| testing system is designed for | ||
| point-of-care settings, hospitals, | ||
| and medical lab facilities. | ||
| Estimation of hematocrit, as a | ||
| function, is only for normal | ||
| hemoglobin values, 12.0 to 18.0 | ||
| g/dL (120 to 180 g/dL) and in | ||
| patients ≥ 6 months old. | ||
| The hemochroma PLUS Controls | ||
| are intended for use as quality | ||
| control material to assure the | ||
| validity and performance of the | ||
| hemochroma PLUS system in | ||
| measuring the human hemoglobin | ||
| concentration. | ||
| The hemochroma PLUS | ||
| Microcuvettes are only used with | ||
| hemochroma PLUS Analyzer. The | ||
| hemochroma PLUS System is for | ||
| in vitro diagnostic only. | ||
| The hemochroma PLUS Analyzer | ||
| calculates the test result | ||
| automatically and displays | ||
| hemoglobin concentration in terms | ||
| of g/dL. | Microcuvettes. The HemoCue Hb | |
| 301 system is for in vitro diagnostic | ||
| use only. The HemoCue Hb 301 | ||
| Analyzer is only to be used with | ||
| HemoCue Hb 301 Microcuvettes. | ||
| Hemoglobin (Hgb) | Same |
Image /page/5/Picture/11 description: The image shows the logo for Immunostics, Inc. The logo features a stylized sunburst symbol to the left of the company name. The text "immunostics, inc." is in a serif font and a light gray color. There are two small circles above the text.
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| Differences | ||
|---|---|---|
| Item | Device | |
| hemochroma PLUS System | ||
| K182298 | Predicate | |
| HemoCue Hb 301 System | ||
| K061047 |
Image /page/6/Picture/3 description: The image shows the logo for Immunostics, Inc. The logo features a stylized red starburst to the left of the company name, which is written in gray, serif font. There are two small red circles above the "nostics" portion of the name. The overall design is simple and professional.
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| Test Principle | Dual wavelengths for Hgb measurement and reference absorption. | Dual wavelengths for Hgb measurement and turbidity compensation. |
|---|---|---|
| Wavelength | Dual wavelengths 530 and 850 nm | Dual wavelengths 506 and 880 nm |
| Measuring Range | 5.0-25.6 g/dL | 0-25.6 g/dL |
| Sample Type | Capillary and venous whole blood | Capillary, venous, and arterial whole blood |
| Test Time | 3 seconds | 10 seconds |
| Sample Volume | 15 μL | 10 μL |
Test Principle:
The hemochroma PLUS Analyzer utilizes a dual wavelength LED light source by which the hemoglobin absorbance is detected and converted into an electrical signal is directly proportional to the amount of hemoglobin present in the sample. The concentration of hemoglobin is calculated based on a pre-programmed calibration. The hemochroma PLUS Microcuvette is specifically designed for the hemochroma PLUS Analyzer. Approximately 15 uL of capillary or venous blood is taken up by capillary action using the tip of the hemochroma PLUS Microcuvette or by direct volume pipetting of the sample. The blood filled Microcuvette is inserted onto the microcuvette holder, and the hemochroma PLUS Analyzer measures the degree of light absorption with a spectrophotometer. The absorbance of the light from the hemochroma PLUS Microcuvette is converted into an electrical signal. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and permits photometric determination of the hemoglobin in undiluted blood samples.
Analytical performance:
- a. Precision/Reproducibility:
Repeatability
Repeatability was assessed in-house using three hemochroma PLUS Microcuvette test lots, three hemochroma PLUS Analyzers, three operators and one lot of hemochroma PLUS Controls (low, middle, and high hemoglobin). Five test samples collected in K2EDTA tubes with hemoglobin concentrations evenly distributed throughout the lower and upper limits and medical decision levels of the analytical measuring range of the hemochroma PLUS Analyzer were tested. Each hemochroma PLUS Analyzer was tested seven times in duplicate (duplicate runs in the morning and duplicate runs in the evening) for a total of 84 tests results for each hemoglobin concentration. Sample Level 1 (5.6 g/dL) and Sample Level 5 (23.7 g/dL) were prepared by spiking natural human whole blood samples. Sample Levels 2 (11.3
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g/dL), 3 (14.6 g/dL), and 4 (18.4 g/dL) were sourced from unmodified natural samples. Repeatability results were within the defined acceptance criteria. Three additional repeatability studies were accessed in-house using five test samples collected in K2EDTA tubes with hemoglobin concentrations evenly distributed throughout the lower and upper limits and medical decision levels of the analytical measuring range of the hemochroma PLUS Analyzer.
Between Operator: In order to evaluate the performance for repeatability between operators, three operators conducted the testing with five hemoglobin levels of test samples using the same lot of the hemochroma PLUS Microcuvette and the same instrument. Each operator repeated the test seven times in duplicate runs in the morning and duplicate runs in the evening).
Between Lot: In order to evaluate the performance for repeatability between the hemochroma PLUS Microcuvette lots, one operator conducted the testing with five hemoglobin levels of test samples using three different lots of hemochroma PLUS Microcuvette and the same instrument. Each Microcuvette lot was tested seven times in duplicate runs (duplicate runs in the morning and duplicate runs in the evening).
Between Instrument: In order to evaluate the performance for repeatability between instruments, one operator conducted the testing with five hemoglobin levels of test samples using one lot of hemochroma PLUS Microcuvette and three different hemochroma PLUS instruments.
| Repeatability Studies | Within Run | Between Run | Between Lot | Between Instrument | Between Operator | Total | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | |||||||||||||||
| Level | N | Mean | |||||||||||||
| (g/dL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| Hgb | 5.6 | 84 | 5.6 | 0.09 | 1.68 | 0.09 | 1.68 | 0.09 | 1.60 | 0.09 | 1.69 | 0.09 | 1.56 | 0.20 | 3.67 |
| 11.3 | 84 | 11.3 | 0.10 | 0.84 | 0.10 | 0.85 | 0.11 | 0.93 | 0.10 | 0.92 | 0.10 | 0.87 | 0.23 | 1.97 | |
| 14.6 | 84 | 14.6 | 0.09 | 0.84 | 0.09 | 0.61 | 0.09 | 0.59 | 0.09 | 0.62 | 0.10 | 0.66 | 0.21 | 1.38 | |
| 18.4 | 84 | 18.4 | 0.09 | 0.49 | 0.09 | 0.49 | 0.09 | 0.51 | 0.09 | 0.47 | 0.10 | 0.53 | 0.21 | 1.11 | |
| 23.7 | 84 | 23.7 | 0.11 | 0.47 | 0.11 | 0.47 | 0.11 | 0.45 | 0.11 | 0.48 | 0.12 | 0.50 | 0.25 | 1.06 |
Results calculated from the repeatability studies including the three additional are represented in table (1) below.
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Reproducibility
Reproducibility was conducted at three intended use sites over 20 operating days utilizing three hemochroma PLUS Microcuvette lots (one lot per site), three hemochroma PLUS Analyzers (one instrument per site), and one lot of hemochroma PLUS Controls (low, middle, and high hemoglobin) tested across the three intended use sites. Testing was done twice daily using the same set of controls, for 20 days. Each control set was run, in duplicate (two runs in the morning and 2 runs in the afternoon), independently, by two operators at each site. A total of 160 test results were generated for each control level at each site. Reproducibility results at all test sites were within the defined acceptance criteria.
| Reproducibility Test Results Summary: Site 1 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Within | ||||||||||||
| Run | Between | ||||||||||||
| Run | Between | ||||||||||||
| Day | Between | ||||||||||||
| Operator | Total | ||||||||||||
| Control | |||||||||||||
| Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| Hgb | Low | 160 | 8.5 | 0.9 | 1.01 | 0.9 | 1.01 | 0.9 | 1.01 | 0.08 | 0.94 | 0.18 | 1.99 |
| Middle | 160 | 12.5 | 0.9 | 0.70 | 0.9 | 0.69 | 0.8 | 0.68 | 0.09 | 0.70 | 0.18 | 1.39 | |
| High | 160 | 15.8 | 0.8 | 0.54 | 0.8 | 0.54 | 0.9 | 0.55 | 0.08 | 0.53 | 0.17 | 1.08 |
Reproducibility Test Results Summary: Site 1
| Site 2 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control | |||||||||||||
| Level | N | Mean | Within | ||||||||||
| Run | Between | ||||||||||||
| Run | Between | ||||||||||||
| Day | Between | ||||||||||||
| Operator | Total | ||||||||||||
| Hgb | Low | 160 | 8.5 | 0.9 | 1.03 | 0.9 | 1.03 | 0.9 | 1.03 | 0.09 | 1.03 | 0.18 | |
| Middle | 160 | 12.5 | 0.9 | 0.66 | 0.9 | 0.71 | 0.9 | 0.71 | 0.09 | 0.71 | 0.18 | 1.40 | |
| High | 160 | 15.8 | 0.8 | 0.54 | 0.8 | 0.54 | 0.9 | 0.54 | 0.09 | 0.54 | 0.17 | 1.08 |
Reproducibility Test Results Summary: Site 2
Reproducibility Test Results Summary: Site 3
| Reproducibility Test Results Summary, Site 3 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 3 | Within | ||||||||||||
| Run | Between | ||||||||||||
| Run | Between | ||||||||||||
| Day | Between | ||||||||||||
| Operator | Total | ||||||||||||
| Control | |||||||||||||
| Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| Hgb | Low | 160 | 8.5 | 0.9 | 1.06 | 0.9 | 1.06 | 0.9 | 1.01 | 0.09 | 1.06 | 0.18 | 2.10 |
| Hgb | Middle | 160 | 12.5 | 0.9 | 0.75 | 0.9 | 0.73 | 0.9 | 0.71 | 0.09 | 0.74 | 0.18 | 1.47 |
| Hgb | High | 160 | 15.8 | 0.9 | 0.57 | 0.8 | 0.57 | 0.9 | 0.56 | 0.09 | 0.57 | 0.18 | 1.14 |
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| All sites | Within-Run | Between-Run | Between-Day | Between-Site | Between-Operator | Total | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| Hgb | Low | 480 | 8.4 | 0.09 | 1.02 | 0.09 | 1.03 | 0.09 | 1.02 | 0.09 | 1.03 | 0.09 | 1.03 | 0.20 | 2.30 |
| Hgb | Middle | 480 | 12.5 | 0.09 | 0.70 | 0.09 | 0.71 | 0.09 | 0.70 | 0.09 | 0.72 | 0.09 | 0.72 | 0.20 | 1.59 |
| Hgb | High | 480 | 15.8 | 0.09 | 0.55 | 0.09 | 0.55 | 0.09 | 0.55 | 0.09 | 0.55 | 0.09 | 0.55 | 0.20 | 1.23 |
Combined Sites Reproducibility Test Results
Linearity/assay reportable range:
The linearity study was conducted using low and high-level hemoglobin concentrations prepared from a venous blood sample. A total of eleven hemoglobin concentration levels (2.5, 4.8, 7.1, 9.4, 11.7, 14.1, 16.4, 18.7, 21.0, 23.3, and 25.6) spanning the claimed measuring range of the hemochroma PLUS Analyzer (5.0-25.6 g/dL) were tested in triplicate and analyzed using one hemochroma PLUS Analyzer and one lot of hemochroma PLUS Microcuvettes. The hemochroma PLUS Controls (low, middle, and high) were tested to ensure and confirm the validity of the test results obtained with the hemochroma PLUS Analyzer. The mean result for each concentration was plotted against the expected value. Linear regression was performed and based on the data analysis, the hemochroma PLUS System demonstrated linearity over the claimed measuring range of 5.0-25.6 g/dL.
Traceability, Stability, Expected values (controls, calibrators, or methods):
hemochroma PLUS Controls (low, middle, and high) Value Assignment
The hemochroma PLUS Controls were produced into three levels (low, middle, high). Each control level was tested in 15 replicates using the same lot of hemochroma PLUS Microcuvettes on the hemochroma PLUS Analyzer. The percent difference between the expected value and the mean value of the 15 replicates was calculated. The average of the 15 replicates was set as the mean value: 8.5 g/dL (low control), 12.5 g/dL (middle control), and 16.2 g/dL (high control).
Value assignment was conducted using three hemochroma PLUS Analyzers with three lots of hemochroma PLUS Microcuvettes and one lot of each control level. Each control level was tested in 10 replicates on each hemochroma PLUS Analyzer. All data points for the hemochroma PLUS Analyzers were within the acceptance criteria.
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Quality Control Stability
Closed vial stability was determined by using three lots of hemochroma PLUS Controls (low, middle, and high) stored at refrigerated temperature (2-8°C) and tested one day every month in triplicate for 10 months. Controls should be brought to room temperature 15-30°C before testing. hemochroma PLUS Controls (low, middle, and high) closed vial stability study data support a stability claim of 6 months when stored at 2-8°C.
Open vial stability was determined by using three lots of hemochroma PLUS Controls (low, middle, and high) stored once opened at (2-8°C). The controls were tested every day in triplicate for 17 days. After one hour of leaving the controls outside of the refrigerator, the controls were tested and then placed back in the refrigerator at 2-8°C. The opened vial stability claim has been established at 14 days after opening when stored at 2-8°C after each use.
hemochroma PLUS Microcuvettes Stability
hemochroma PLUS Microcuvettes shelf life stability was determined by using three lots of hemochroma PLUS Microcuvettes stored at 15–35°C. Testing was performed one day per month in triplicate for 27 months. The hemochroma PLUS Controls (low, middle, and high hemoglobin) were tested during the hemochroma PLUS Microcuvettes shelf life stability to ensure and confirm the validity of the test results obtained with the hemochroma PLUS Analyzer. The study data support a shelf life stability claim of 24 months when stored at 15-35°C.
hemochroma PLUS Microcuvettes open container (in-use) stability was determined by using three lots of hemochroma PLUS Microcuvettes stored at 15-35°C. Testing was performed one day per month in triplicate for 27 months. Every month, three lots of hemochroma PLUS Microcuvettes were removed from the container and tested with fresh hemochroma PLUS Controls (low, middle, and high hemoglobin) in triplicate with the hemochroma PLUS Analyzer and each replicate was tested in 1-hour intervals (total of nine test results each month). The study data support a stability claim of 24 months when stored at 15-35°C after the seal is broken.
Sample Stability
The sample stability study was assessed using one lot of hemochroma PLUS Microcuvettes and one hemochroma PLUS Analyzer. Thirty-seven fresh venous blood samples were collected in K2EDTA tubes and measured immediately with the hemochroma PLUS Analyzer. The venous blood test samples were then stored in the refrigerator (2-8℃) and tested at various time intervals (3, 6, 12 hours, and 1, 2, 3, 6, 7 days). The venous blood test samples were inverted gently 10 times to ensure mixing of anticoagulant with blood prior to testing. The venous blood
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test samples stored in the refrigerator were brought to room temperature before testing. Percent recovery was calculated for each venous blood test sample after each time point from the fresh venous blood sample test results. The study data support a stability claim of 24 hours when stored at 2-8°C.
Detection limit:
Limit of Blank (LoB) testing was performed using five blank hemoglobin depleted human plasma samples measured in five replicates tested over a period of 3 days with three different lots of hemochroma PLUS Microcuvettes and three hemochroma PLUS Analyzers for a total of 75 test results per lot of hemochroma PLUS Microcuvettes. LoB was calculated by parametric analysis of the study data. LoB of hemochroma PLUS System was found to be 0.23 g/dL.
LoD testing was performed using six Hgb-low samples prepared by spiking plasma with red blood cells. Five replicates of each of the six Hgb-low samples was tested over a period of 3 days with three different lots of hemochroma PLUS Microcuvettes using one hemochroma PLUS Analyzer for a total of 90 test results per lot of hemochroma PLUS Microcuvettes. LoD was calculated by parametric analysis of the study data. LoD of hemochroma PLUS System was found to be 1.66 g/dL.
Limit of Quantitation (LoQ) was determined by testing six low Hgb samples prepared by spiking plasma with red blood cells. Each sample was tested in five replicates over a period of three days with three different lots of hemochroma PLUS Microcuvettes using one hemochroma PLUS Analyzer for a total of 90 test results per lot of hemochroma PLUS Microcuvettes. The LoQ data are considered acceptable when the % Total-error is smaller than the desired total error for the measurand. LoQ of the hemochroma PLUS System was determined to be 4.5 g/dL.
Analytical specificity:
An interference study was conducted to evaluate the potential of various endogenous and exogenous substances that may affect hemoglobin results. Three hemoglobin levels of human whole blood samples were spiked with various potential interfering substances listed in the table 6 below. Three hemoglobin levels were verified with the HemoCue Hb 301. Control samples (no interfering substances) and test samples (with interfering substances) were tested in five replicates with the hemochroma PLUS Analyzer. All tested interference substances (endogenous and exogenous) showed non-significant interference up to the concentrations given in the table below.
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| Interference Materials | |||
|---|---|---|---|
| Exogenous | |||
| Substances | Test | ||
| Concentration | Endogenous | ||
| Substances | Test | ||
| Concentration | |||
| Acetaminophen | 1324 µmol/L | Bilirubin (conj.) | 342 µmol/L |
| Ammonium Ferric | |||
| citrate | 300 mg/L | Cholesterol | 13 µmol/L |
| Ascorbic Acid | 342 µmol/L | Creatinine | 442 µmol/L |
| Ferrous Sulfate | 222 mg/L | Protein (Total) | 120 g/L |
| Ferrous Fumarate | 300 mg/L | Triglycerides | 37 mmol/L |
| Folic Acid | 7.5 mg/L | Urea | 42.9 mmol/L |
| Ibuprofen | 2425 µmol/L | Uric acid | 1.4 mmol/L |
| Iron Dextran | 2838 mg/L | ||
| Salicylic Acid | 4.34 mmol/L | ||
| Tetracycline | 34 µmol/L | ||
| Vitamin B12 | 1000 pg/mL |
Potential Interfering substances (Endogenous and Exogenous)
Method comparison with predicate device:
Method comparison study was performed at three point-of-care clinical sites in the United States to assess the performance of the hemochroma PLUS System compared to the predicate device (HemoCue Hb 301 System) utilizing a total of 60 capillary finger-stick blood samples and 60 venous blood samples in K2EDTA tubes. An additional 10 hemoglobin samples in extreme hemoglobin ranges were spiked in order to assess performance at the lower and upper ends of the measurement range (for venous blood samples only). Testing was performed using three hemochroma PLUS Analyzers (one at each site), three operators (one at each site), and three lots of the hemochroma PLUS Microcuvettes (one at each site). The hemochroma PLUS Controls (low, middle, and high hemoglobin) were run prior to testing. Linear regression analyses demonstrate comparable performance between hemochroma PLUS System and HemoCue Hb 301 System across the analytical measuring range. The method comparison study demonstrated that the analytical performance of the hemochroma PLUS System test is substantially equivalent to the predicate device.
95% CI Slope N Sample Type Intercept (95% CI) Intercept
Summary of Method Comparison Study
Image /page/13/Picture/6 description: This table shows the correlation coefficient for a capillary sample at site 1. The sample size is 60. The slope is 0.9942 with a 95% confidence interval of -0.650 to 0.892. The intercept is 0.1214 with a 95% confidence interval of 0.941 to 1.048, and the correlation coefficient is 0.980.
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| 1 | Venous | 70 | 1.0140
(-0.468, 0.083) | -0.1924 | -0.1924
(0.995, 1.033) | 0.997 |
|---|-----------|----|---------------------------|---------|---------------------------|-------|
| 2 | Capillary | 60 | 1.0007
(-1.016, 0.998) | -0.0089 | -0.0089
(0.932, 1.070) | 0.967 |
| 2 | Venous | 70 | 0.9971
(-0.136, 0.437) | 0.1506 | 0.1506
(0.978, 1.016) | 0.997 |
| 3 | Capillary | 60 | 0.9994
(-0.872, 0.980) | 0.0542 | 0.0542
(0.935, 1.064) | 0.971 |
| 3 | Venous | 70 | 1.0042
(-0.263, 0.289) | 0.0129 | 0.0129
(0.985, 1.023) | 0.997 |
Matrix comparison:
A matrix comparison study was performed to demonstrate comparability between venous whole blood samples and capillary whole blood samples using the hemochroma PLUS Analyzer. The matrix comparison was performed using whole blood (venous and capillary) from 80 study participants with one hemochroma PLUS Microcuvette lot and one hemochroma PLUS Analyzer. The hemochroma PLUS Controls (low, middle, and high) were run prior to testing. Percent difference between capillary blood and venous blood (K2EDTA) was calculated. A Bland-Altman plot was used to analyze the agreement between capillary blood and venous blood. The results of the Bland-Altman plot analysis and % difference between venous whole blood samples and capillary whole blood samples on the hemochroma PLUS Analyzer met the acceptance criteria.
Reference Range:
The reference ranges were based on the existing medically accepted published reference ranges.
| Group | Cited Reference Range1,2 |
|---|---|
| 2-6 months | 9.5-13.5 g/dL |
| 7 months-2 years | 10.5-14.0 g/dL |
| 3-6 years | 11.5-14.5 g/dL |
| 7-12 years | 11.5-15.5 g/dL |
| 13-18 years Male | 13.0-16.0 g/dL |
| 13-18 years Female | 12.0-16.0 g/dL |
| Adult Male | 14.0-18.0 g/dL |
| Adult Female | 12.0-16.0 g/dL |
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Billett, HH. Hemoglobin and Hematocrit. Clinical Methods: The History, Physical, and Laboratory Examinations. Boston: Butterworths, 3rd edition, 1990: chapter 151.
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Andropoulos, Dean B., and George A. Gregory's Pediatric Anesthesia. 5th ed., Wiley-Blackwell, 2012.
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Specimen Identification:
There is no sample identification for the hemochroma PLUS Analyzer. Samples are applied directly to the microcuvettes as they are collected. The end user must develop a manual system to identify patients that are tested with the hemochroma PLUS Analyzer.
Specimen Sampling and Handling:
Capillary or venous whole blood is directly applied from the finger or blood tube (using a disposable pipette) to the Microcuvette. Wipe off excess blood from the surface of the microcuvette using a piece of soft gauze. The blood-filled Microcuvette is then inserted into the hemochroma PLUS Analyzer.
Calibration:
The hemochroma PLUS Optical System Check is used to assure the performance of the Optic System of the hemochroma PLUS.
Ouality Control:
The hemochroma PLUS Controls (low, middle, and high hemoglobin) are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS System in measuring the human hemoglobin concentration. The hemochroma PLUS Controls should be assayed according to the manufacturer's instructions and following the local and state guidelines. If controls do not perform as expected, the test results should not be used.
Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
-
- Comparison of hemochroma PLUS Analyzer and HemoCue Hb 301 Analyzer for Disease Conditions:
A study was conducted to determine the hemochroma PLUS Analyzer and HemoCue Hb 301 Analyzer performance when testing certain disease conditions. Venous blood specimens were collected from diseased donors: 3 specimens from donors with Polycythemia, 2 specimens from the donors with hypochromia, 3 specimens from the donors with high WBC count, and 2 specimens from sickle cell donors. Each test specimen was tested 5 times with the HemoCue Hb 301 Analyzer and 5 times with the hemochroma PLUS Analyzer. These results indicate that hemochroma PLUS System hemoglobin assay meets the expected performance criteria therefore, no interference was observed in these disease conditions.
- Comparison of hemochroma PLUS Analyzer and HemoCue Hb 301 Analyzer for Disease Conditions:
-
- Anticoagulant Comparison (K2EDTA vs K3EDTA, Lithium Heparin, Sodium Heparin, and Sodium Citrate):
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- Anticoagulant Comparison (K2EDTA vs K3EDTA, Lithium Heparin, Sodium Heparin, and Sodium Citrate):
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To evaluate the effect of anticoagulants (K2EDTA, Lithium Heparin, Sodium Heparin, and Sodium Citrate) on the performance of the hemochroma PLUS Analyzer, venous blood was collected in each of 2.0 mL anticoagulant tubes (K2EDTA, Lithium Heparin, Sodium Heparin, and Sodium Citrate) from 50 study participants. Spiked plasma samples were used for hemoglobin concentrations in the extreme hemoglobin (low and high) measuring ranges. The % difference between K2EDTA and 4 different anticoagulants (K3EDTA, Lithium heparin, Sodium heparin, and Sodium Citrate) was calculated. A Bland-Altman plot was used to analyze the agreement between the K2EDTA tube and the 4 other anticoagulant tubes. The results of the Bland-Altman plot analysis and % difference between the K2EDTA tube and 4 different anticoagulants on the hemochroma PLUS Analyzer were within the defined acceptance criteria.
3. Cleaning Disinfection and Robustness Testing:
To perform the hemochroma PLUS Analyzer cleaning step, the operator should use a Micro-Kill Bleach Germicidal Bleach Wipe to wipe all surface areas of the analyzer to remove all blood and other body fluids. During the hemochroma PLUS Analyzer disinfection step, the operator uses Micro-Kill Bleach Germicidal Bleach Wipes to thoroughly wet all surface areas of the analyzer. The operator also carefully disinfects the entire surface of the hemochroma PLUS Instrument and the holder for microcuvettes with the Micro-Kill Bleach Germicidal Bleach Wipes. There was a minimum 5-minute rest period between each the cleaning.
The hemochroma PLUS Analyzer lifespan claim is 27375 cleaning cycles which is equivalent to 3 years of analyzer life.
One (1) cycle = One (1) wipe for cleaning + One (1) wipe for disinfecting 25 cleaning cycles per day x 365 days x (3) years = 27375 cleaning cycles.
The lifespan of the analyzer will vary depending on actual usage.
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Standard/Guidance Document Referenced (if applicable):
| No. | Standard
Developing
Organization | Title of Standard | Date |
|-----|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------|
| 1 | CLSI Reference
Standard | EP05-A3: Evaluation of Precision of Quantitative
Measurement Procedures; Approved Guideline-Third
Edition | 08/14/2015 |
| 2 | CLSI Reference
Standard | EP6-A: Evaluation of Linearity of Quantitative
Measurement Procedures: A Statistical Approach;
Approved Guideline | 01/30/2014 |
| 3 | CLSI Reference
Standard | EP07-A2: Interference Testing in Clinical Chemistry;
Approved Guideline-Second Edition | 05/21/2007 |
| 4 | CLSI Reference
Standard | EP09-A3: Measurement Procedure Comparison and
Bias Estimation Using Patient Samples; Approved
Guideline-Third Edition | 01/30/2014 |
| 5 | CLSI Reference
Standard | EP14-A3: Evaluation of Commutability of Processed
Samples; Approved Guideline-Third Edition | 08/14/2015 |
| 6 | CLSI Reference
Standard | EP17-A2: Evaluation of Detection Capability for
Clinical Laboratory Measurement Procedures;
Approved Guideline-Second Edition | 01/15/2013 |
| 7 | CLSI Reference
Standard | EP25-A: Evaluation of Stability of In Vitro
Diagnostic Reagents; Approved Guideline | 01/15/2013 |
| 8 | CLSI Reference
Standard | EP25-A: Evaluation of Stability of In Vitro
Diagnostic Reagents; Approved Guideline | 01/15/2013 |
| 9 | CLSI Reference
Standard | EP28-A3C: Defining, Establishing, and Verifying
Reference Intervals in the Clinical Laboratory;
Approved Guideline-Third Edition | 01/30/2014 |
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