The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K.2-EDTA, sodium citrate, lithium heparin, or sodium heparin) of adults. The testing system is designed for point-of-care use in primary care settings, hospitals, and medical lab facilities. Estimation of hematocrit, as a function, is only for normal hemoglobin values from 12.0 to 18.0 g/ dL (120 to 180 g/L).

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. This device has not been evaluated for pediatric samples. The device has been evaluated for individuals ranging in age from 18 to 96 years old. The hemochroma PLUS System is for in vitro diagnostic only.

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 pre-processing. 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 a 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.

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 by placing it into the cuvette holder. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and by measuring the degree of light absorption permits photometric determination of the hemoglobin in undiluted blood samples.
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 hemochroma PLUS Controls: Level 1 (Low), Level 2 (Middle), and Level 3 (High), are external quality controls designed for use with hemochroma PLUS Analyzer only.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study proving the device's performance:

The document is a 510(k) Summary for the "hemochroma PLUS System," an automated hemoglobin system. It outlines the analytical performance studies conducted to establish substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" for each study in a table format. Instead, it states for each analytical study that the "results were within the defined acceptance criteria" or "met the acceptance criteria." This implies that internal acceptance criteria were pre-established by the manufacturer for each test (e.g., repeatability, reproducibility, linearity, interference, method comparison, stability, detection limits) and the observed performance successfully satisfied them.

However, based on the provided results, we can infer some performance metrics:

Study/Parameter	Acceptance Criteria (Inferred)	Reported Device Performance
Repeatability (CV%)	Not explicitly stated; implied to be acceptable for various Hb levels.	Within Run %CV: < 1.7% (max for 5.6 g/dL) Between Run %CV: < 1.7% Between Lot %CV: < 1.7% Between Instrument %CV: < 1.7% Between Operator %CV: < 1.6% Total %CV: < 3.7% (max for 5.6 g/dL)
Reproducibility (CV%)	Not explicitly stated; implied to be acceptable.	Combined Sites Total %CV: < 2.3% (max for Low Control)
Linearity/Reportable Range	Implied to show linearity over the claimed range.	Demonstrated linearity over 5.0-25.6 g/dL.
Limit of Blank (LoB)	Implied to be acceptable.	0.23 g/dL
Limit of Detection (LoD)	Implied to be acceptable.	1.66 g/dL
Limit of Quantitation (LoQ)	% Total-error smaller than desired total error.	4.5 g/dL
Analytical Specificity (Interference)	Non-significant interference.	All tested substances showed non-significant interference up to specified concentrations.
Method Comparison (vs. Predicate)	Comparable performance (e.g., acceptable slope, intercept, correlation).	Correlation Coefficient (r): 0.967 to 0.997 across sites and sample types. Slopes: Close to 1 (e.g., 0.9942 to 1.0140). Intercepts: Close to 0.
Matrix Comparison	Agreement between venous and capillary samples.	Bland-Altman plot analysis and % difference met acceptance criteria.
QC Stability	Implied to demonstrate claimed stability.	Closed vial: 6 months at 2-8°C. Open vial: 14 days at 2-8°C.
Microcuvette Stability	Implied to demonstrate claimed stability.	Shelf life: 24 months at 15-35°C. Open container: 24 months at 15-35°C.
Sample Stability	Implied to demonstrate claimed stability.	24 hours when stored at 2-8°C.
Disease Conditions Testing	Meets expected performance criteria; no interference.	No interference observed in Polycythemia, Hypochromia, High WBC, Sickle Cell samples.
Anticoagulant Comparison	Agreement between K2EDTA and other anticoagulants.	Bland-Altman plot analysis and % difference met acceptance criteria for K3EDTA, Lithium Heparin, Sodium Heparin, and Sodium Citrate.

Study Details:

A table of acceptance criteria and the reported device performance:
- See table above. The document generally states "met acceptance criteria" without providing the specific numerical cutoffs for most criteria. The reported performance details are extracted from the text where available (e.g., specific %CV values, correlation coefficients).
Sample sizes used for the test set and the data provenance:
- Repeatability:
  - In-house study: Five test samples (K2EDTA tubes) with distributed hemoglobin concentrations. Each of 3 analyzers tested 7 times in duplicate (morning/evening) for a total of 84 results per sample level.
  - Between Operator: 5 hemoglobin levels, 3 operators, 7 times in duplicate.
  - Between Lot: 5 hemoglobin levels, 3 microcuvette lots, 7 times in duplicate.
  - Between Instrument: 5 hemoglobin levels, 3 instruments, 7 times in duplicate.
- Reproducibility:
  - Three intended use sites.
  - Sample size: 160 test results per control level at each site. This implies 3 levels * 160 results/site * 3 sites = 1440 control results in total for the main reproducibility study.
- Linearity/Reportable Range: Eleven hemoglobin concentration levels. Tested in triplicate.
- Limit of Blank: 5 blank samples, 5 replicates each, over 3 days (total of 75 results per microcuvette lot).
- Limit of Detection: 6 low-Hgb samples, 5 replicates each, over 3 days (total of 90 results per microcuvette lot).
- Limit of Quantitation: 6 low-Hgb samples, 5 replicates each, over 3 days (total of 90 results per microcuvette lot).
- Analytical Specificity (Interference): Three hemoglobin levels, control and test samples, tested in 5 replicates.
- Method Comparison:
  - 60 capillary finger-stick blood samples.
  - 60 venous blood samples (K2EDTA).
  - Additional 10 venous samples in extreme hemoglobin ranges (for venous data only).
  - Total sample size for method comparison appears to be approximately 130 patient samples (60 capillary + 70 venous).
- Matrix Comparison: 80 study participants (venous and capillary whole blood).
- Sample Stability: 37 fresh venous blood samples (K2EDTA tubes).
- Disease Conditions: 10 specimens (3 Polycythemia, 2 Hypochromia, 3 High WBC, 2 Sickle Cell). Each tested 5 times.
- Anticoagulant Comparison: 50 study participants (venous blood collected in 4 different anticoagulant tubes).
- Data Provenance:
  - Repeatability and Detection Limits: "in-house"
  - Reproducibility: "at three intended use sites" (implies prospective, real-world conditions).
  - Method Comparison: "at three point-of-care clinical sites in the United States" (implies prospective, real-world conditions).
  - Matrix Comparison, Sample Stability, Disease Conditions, Anticoagulant Comparison: Performed using collected blood samples but location/nature (retrospective/prospective) not explicitly stated for all. The collection of "fresh venous blood samples" and samples from "study participants" suggests prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A) / Not provided. For this type of in vitro diagnostic device (automated hemoglobin system), the "ground truth" for analytical performance studies is typically established by reference methods or validated laboratory measurements (e.g., using a predicate device or a clinical laboratory analyzer as a comparison), not by expert human graders or adjudicators of images.
- The "HemoCue Hb 301 System" is used as the predicate device for method comparison, which serves as the "truth" or comparison standard in that study. For other studies like repeatability and reproducibility, the device's own measurements against each other, or against controls/calibrators, form the basis of the evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. This concept of "adjudication" (common in image analysis AI models where human readers interpret data) does not apply to the analytical performance testing of a quantitative laboratory device like the hemochroma PLUS System. Measurements are objective numerical values.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that aid human interpretation (e.g., radiologists reading images) to show improvement in diagnostic accuracy or efficiency. The hemochroma PLUS System is a quantitative measuring device, not an AI assistance tool for human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. All the analytical performance studies (repeatability, reproducibility, linearity, detection limits, interference, stability studies, and even the method comparison with the predicate) demonstrate the performance of the "algorithm only" or the device itself in producing quantitative hemoglobin results. Human involvement primarily pertains to sample collection, handling, and operating the device, not interpreting its output or providing a diagnosis based on visual assessment that the algorithm then aids.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference standard for this device is primarily established through:
  - Comparison to a legally marketed predicate device (HemoCue Hb 301 System) for method comparison studies.
  - Validated laboratory methods and samples (e.g., spiked samples, control materials with assigned values, reference measurements) for studies like linearity, detection limits, and interference.
  - Internal consistency and precision metrics for repeatability and reproducibility studies.
The sample size for the training set:
- No specific "training set" is mentioned in the context of device development for this 510(k) submission. The hemochroma PLUS System is described as using a "pre-programmed calibration" and an "ID chip" with "calibration data/information." This suggests that the device's measurement algorithm is based on a fixed, pre-established calibration curve rather than a machine learning model that requires a "training set" to learn from data. Therefore, the concept of a training set as understood in AI/ML development is not directly applicable or described here.
How the ground truth for the training set was established:
- N/A. As explained above, there is no mention of a "training set" in the context of an AI/ML model for this device. The device operates on optical principles and a pre-programmed calibration curve. The value assignment for controls and the calibration data on the ID chip would have been established through a rigorous internal validation process using reference methods and materials, though the specifics of that process are not detailed as a "ground truth" for a "training set."

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

November 9, 2018

Immunostics, Inc. Antoinette Prusik Director of Regulatory Affairs 1750 Brielle Ave. A5 Ocean, New Jersey 07712

Re: K163465

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: December 8, 2016 Received: December 12, 2016

Dear Antoinette Prusik:

This letter corrects our substantially equivalent letter of September 8, 2017.

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.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 531-542 of the Act); 21 CFR 1000-

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K163465

Device Name hemochroma PLUS System

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a red icon of the letter 'i' inside a red square. The letter 'i' is also red and has a circular dot above a rectangular body. The icon appears to be a glossy, digital rendering, possibly used to indicate information or details.

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 E-mail: ohj@boditech.co.kr Website: www.boditech.co.kr Establishment Registration Number: 3009491259

Regulatory Correspondent

Immunostics, Inc. 1750 Brielle Ave Ste A5 Ocean, New Jersey 07712 Phone No .: (732) 918-0770 Ext. 402 Fax No .: (732) 918-0618 Contact: Antoinette Prusik E-mail: aprusik@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 § 862.1660 510(k) Number: K163465 Classification Name: Automated hemoglobin system, Hematology quality control mixture Regulatory Class: Class II Panel: Hematology Product Code: GKR, JJX Predicate Device: HemoCue Hb 301 System Predicate 510(k) Number: K061047

Image /page/3/Picture/11 description: The image shows the logo for Immunostics, Inc. The logo features a stylized sunburst to the left of the text "immunostics, inc.". The text is in a serif font and is a light gray color. The logo is simple and clean, and it is likely used on the company's website and marketing materials.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows a red and white icon. The icon is a red rectangle with a white border. Inside the rectangle is a white letter "i" with a circle above it. The letter "i" and the circle are also outlined in red. The icon is likely used to represent information or an information button.

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, or sodium heparin) of adults. The testing system is designed for point-of-care use in primary care settings, hospitals, and medical lab facilities. Estimation of hematocrit, as a function, is only for normal hemoglobin values from 12.0 to 18.0 g/dL (120 to 180 g/L).

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.

Device Description:

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.

1. 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 by placing it into the cuvette holder. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and by measuring the degree of light

Image /page/4/Picture/12 description: The image shows the logo for "immunostics, inc.". The logo is in gray and has a stylized sunburst to the left of the word "immunostics". The word "inc." is smaller and to the right of "immunostics".

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image is a red and white icon. The icon is a red rectangle with a white border. Inside the rectangle is a white letter "i" with a red outline. The letter "i" has a circle above it.

absorption permits photometric determination of the hemoglobin in undiluted blood samples.

1. 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.
1. 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.
1. hemochroma PLUS Controls
  The hemochroma PLUS 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	Devicehemochroma PLUS SystemK163465	PredicateHemoCue Hb 301 SystemK061047
IntendedUse/Indicationsfor Use	The hemochroma PLUS Systemis for the quantitativedetermination of hemoglobinconcentration in non-anticoagulated capillary (finger-stick) whole blood or venouswhole blood (K2EDTA,K3EDTA, sodium citrate, lithiumheparin, or sodium heparin) ofadults. The testing system isdesigned for point-of-care use inprimary care settings, hospitals,	The HemoCue Hb 301 System isdesigned for quantitative point-of-care whole blood hemoglobindetermination in primary careusing a specially designedanalyzer, the HemoCue Hb 301Analyzer, and specially designedmicrocuvettes, the HemoCue Hb301 Microcuvettes. TheHemoCue Hb 301 system is for invitro diagnostic use only. TheHemoCue Hb 301 Analyzer is

Image /page/5/Picture/12 description: The image shows the logo for Immunostics, Inc. The logo is in gray and features a stylized starburst to the left of the word "Immunostics". The word "inc." is written in a smaller font to the right of "Immunostics".

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a red and white icon. The icon is a red rectangle with rounded corners, and inside the rectangle is a white "i" with a circle above it. The icon is likely used to represent information or details.

Similarities
Item	Devicehemochroma PLUS SystemK163465	PredicateHemoCue Hb 301 SystemK061047
	and medical lab facilities.Estimation of hematocrit, as afunction, is only for normalhemoglobin values from 12.0 to18.0 g/dL (120 to 180 g/L).The hemochroma PLUS Controlsare intended for use as qualitycontrol material to assure thevalidity and performance of thehemochroma PLUS System inmeasuring the human hemoglobinconcentration.The hemochroma PLUSMicrocuvettes are only used withhemochroma PLUS Analyzer.This device has not beenevaluated for pediatric samples.The device has been evaluated forindividuals ranging in age from18 to 96 years old. Thehemochroma PLUS System is forin vitro diagnostic only.	only to be used with HemoCueHb 301 Microcuvettes.
Parameter(s)	Hemoglobin (Hgb)	Same

	Differences
Item	Devicehemochroma PLUS SystemK163465	PredicateHemoCue Hb 301 SystemK061047
Test Principles	Dual wavelengths for Hgbmeasurement and referenceabsorption.	Dual wavelengths for Hgbmeasurement and turbiditycompensation.
Wavelength	Dual wavelengths 530 and 850nm	Dual wavelengths 506 and 880nm
MeasuringRange	5.0-25.6 g/dL	0-25.6 g/dL
Sample Type	Capillary and venous whole blood	Capillary, venous, and arterialwhole blood

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows a red and white sign with a stylized letter "i" in the center. The "i" is white and consists of a circle above a rectangle. The sign has a red border and a white background, creating a high contrast. The sign appears to be glossy, reflecting light.

Differences
Item	Devicehemochroma PLUS SystemK163465	PredicateHemoCue Hb 301 SystemK061047
Test Time	3 seconds	10 seconds
Sample Volume	15μL	10μL

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:

Repeatability

Repeatability was assessed in-house using three hemochroma PLUS Microcuvette test lots, three hemochroma PLUS Analyzers, three operators and 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 (7) 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.

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

Image /page/7/Picture/9 description: The image shows the logo for Immunosotics, Inc. The logo features a stylized sunburst to the left of the company name. The text is in a serif font and appears to be gray in color.

750 Brielle Ave. · A5 · Ocean. New Jersey · 07712 00) 722-7505 · Fax: (732) 918-061 www.lmmunostics.com

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows a red icon with a white background. The icon is a stylized letter "i" with a circle above it, both in red. The icon is enclosed in a red rectangle with a white border, giving it a glossy, three-dimensional appearance.

PLUS Analyzer were tested.

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 (duplicate runs in the morning and duplicate runs in the evening) runs.

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 (7) times in duplicate runs in the morning and duplicate runs in the evening) runs.

Between Instrument: In order to evaluate the performance for repeatability between the 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.

Results calculated from the repeatability studies including the three additional are represented in the table below.

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
Hgb	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
Hgb	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
Hgb	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
Hgb	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

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

Image /page/8/Picture/11 description: The image shows the logo for Immunostics, Inc. The logo features a stylized sunburst to the left of the text "immunostics, inc.". The text is in a serif font and appears to be gray in color.

) Brielle Ave. · A5 · Ocean. New Jersey · 07712 505 · Fax: (732) 918-061 ww.lmmunostics.com

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows a red and white icon. The icon is a red letter "i" inside of a red rectangle. The letter "i" is white and has a red circle above it.

	Site 1			WithinRun		BetweenRun		BetweenDay		BetweenOperator		Total
	ControlLevel	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
	Low	160	8.5	0.9	1.01	0.9	1.01	0.9	1.01	0.08	0.94	0.18	1.99
Hgb	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 2

Site 2		WithinRun		BetweenRun		BetweenDay		BetweenOperator		Total
	ControlLevel	N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
	Low	160	8.5	0.9	1.03	0.9	1.03	0.9	1.03	0.09	1.03	0.18	2.16
Hgb	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 3

Site 3			WithinRun		BetweenRun		BetweenDay		BetweenOperator		Total
ControlLevel		N	Mean	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
	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
	High	160	15.8	0.9	0.57	0.8	0.57	0.9	0.56	0.09	0.57	0.18	1.14

Combined Sites Reproducibility Test Results

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
	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
	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

Linearity/assay reportable range:

Image /page/9/Picture/10 description: The image shows the logo for "Immunostics, Inc.". The logo features a stylized sunburst to the left of the text. The text is in a serif font and is a light gray color. The logo is simple and clean, and it is likely used to represent the company's brand.

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows a red icon of the letter 'i' inside a red rectangle. The letter 'i' is stylized with a circle above a vertical line, both in red. The background of the icon is white, and there is a subtle gradient effect that gives the icon a glossy appearance. The icon is simple and easily recognizable.

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.

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

Image /page/10/Picture/11 description: The image shows the logo for "Immunostics, Inc." The logo is in a serif font and is a light gray color. To the left of the word "Immunostics" is a symbol that looks like a starburst with a horizontal line through the middle.

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image shows a red and white sign with a stylized "i" in the center. The "i" is composed of a circle on top of a rectangle. The sign has a glossy finish, suggesting it might be made of plastic or metal. The background is white, and the "i" is red, creating a high contrast and making it easily visible.

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℃ 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 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

Image /page/11/Picture/9 description: The image shows the logo for "immunostics, inc.". The logo features a stylized starburst to the left of the text. The text is in a serif font and appears to be embossed or have a 3D effect.

{12}------------------------------------------------

Image /page/12/Picture/1 description: The image shows a red and white sign with a stylized "i" in the center. The "i" is white, and it is surrounded by a red border. The sign is rectangular, and it has a glossy finish. The sign likely indicates information or a point of interest.

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. LoO 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.

Interference Materials
Exogenous	Test	Endogenous	Test
Substances	Concentration	Substances	Concentration
Acetaminophen	1324 umol/L	Bilirubin (conj.)	342 umol/L
Ammonium Ferriccitrate	300 mg/L	Cholesterol	13 umol/L
Ascorbic Acid	342 umol/L	Creatinine	442 umol/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 umol/L	Uric acid	1.4 mmol/L
Iron Dextran	2838 mg/L
Salicylic Acid	4.34 mmol/L
Tetracycline	34 umol/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

Image /page/12/Picture/13 description: The image shows the logo for Immunostics, Inc. The logo features a stylized sunburst to the left of the company name, which is written in a serif font. The letters are shaded to give a three-dimensional effect. The word "inc." is written in a smaller font size and is slightly offset to the right.

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image is a red and white sign with a stylized letter "i" in the center. The "i" is composed of a vertical rectangle with a circle above it. The sign has a red border and a white background. The sign appears to be a glossy or reflective material.

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.

Site #	Sample Type	N	Slope(95% CI)	Intercept	95% CIIntercept	CorrelationCoefficient(r)
1	Capillary	60	0.9942(-0.650, 0.892)	0.1214	0.1214(0.941, 1.048)	0.980
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

Summary of Method Comparison Study

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:

Image /page/13/Picture/8 description: The image shows the logo for Immunosotics, Inc. The logo features a stylized sunburst to the left of the company name. The text is in a serif font and appears to be in a gray color.

{14}------------------------------------------------

Image /page/14/Picture/1 description: The image is a red and white icon. The icon is a red letter "i" inside of a red rectangle. The letter "i" is white and has a red circle above it. The background of the icon is white.

The reference ranges were based on the existing medically accepted published reference ranges.

Reference Range
Group	Cited Reference Range
Adult Male	14.0-18.0 g/dL
Adult Female	12.0-16.0 g/dL

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 1. 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

Image /page/14/Picture/15 description: The image shows the logo for "Immunostics, inc.". The logo is in gray and has a starburst design on the left side. The text is in a serif font and has a slightly shadowed effect.

{15}------------------------------------------------

Image /page/15/Picture/1 description: The image shows a red icon of the letter 'i' inside a red rectangular border. The letter 'i' is stylized with a circle above a vertical line, both in red. The background of the icon is a gradient of white to light gray, giving it a glossy appearance. The icon is simple and likely represents information or an informational resource.

hemoglobin assay meets the expected performance criteria therefore, no interference was observed in these disease conditions.

1. Anticoagulant Comparison (K2EDTA vs K3EDTA, Lithium Heparin, Sodium Heparin, and Sodium Citrate):
  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.
1. 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.

Image /page/15/Picture/10 description: The image shows the logo for Immunostics, Inc. The logo features a stylized sunburst to the left of the company name, which is written in a serif font. The text is a light gray color, and the sunburst is made up of thin lines radiating from a central point.

Regulation Number and Section

§ 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).

Acceptance Criteria and Reported Device Performance

Study Details:

Leonthena R. Carrington -S

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

Section 8: 510(k) Summary

hemochroma PLUS System

Sponsor's Information

Regulatory Correspondent

Device Information

Intended use(s):

Device Description:

Substantial Equivalence Information:

Test Principle:

Analytical performance:

Repeatability

Reproducibility

hemochroma PLUS Controls (low, middle, and high) Value Assignment

Quality Control Stability

hemochroma PLUS Microcuvettes Stability

Sample Stability

Detection limit:

Analytical specificity:

Potential Interfering substances (Endogenous and Exogenous)

Method comparison with predicate device:

Summary of Method Comparison Study

Matrix comparison:

Reference Range:

Specimen Identification:

Specimen Sampling and Handling:

Calibration:

Ouality Control:

Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

§ 864.5620 Automated hemoglobin system.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW