The Mission® Plus Hemoglobin (Hb) Testing System is for the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA ( K2, K3, Na2) or sodium heparin. The testing system is designed for point-of-care use in primary care settings. Estimation of hematocrit is only for hemoglobin values from 12.3 to 17.5 g/dL (123 to 175 g/L).

The Mission® Plus Hemoglobin (Hb) Control Solution is intended to validate hemoglobin testing using the Mission® Plus Hemoglobin (Hb) Testing System.

The Mission® Plus Hemoglobin (Hb) Testing System is for professional in vitro diagnostic use only.

Device Description

The Mission® Plus Hemoglobin Testing System consists of The Mission® Hemoglobin (Hb) Testing Meter, Test cartridge, Control Solutions, and Optical Verifier.

The Test cartridges are used with the Meter for monitoring Hemoglobin (Hb) and estimate the Hematocrit (Hct) within normal range of hemoglobin in capillary or venous whole blood. Red blood cells in the specimen are lysed to release Hb, which is converted into MHb. The shade of the color produced depends on the concentration of Hb.

The Mission® plus Hemoglobin Testing System is a small, portable, battery-powered meter to measure total hemoglobin in combination of disposable test cartridge and requires no sample preparation or reagents. The portable meter analyzes the intensity and color of light reflected from the reagent area of a Test cartridge and provides results in less than 15 seconds. The test only requires a single drop of whole blood. The meter can store up to 1,000 results data and the data can be transferred to a computer for further analysis using the USB port. The meter can be powered by 4 AAA (1.5V) batteries or an optional AC adapter.

The Mission® Plus Hemoglobin (Hb) Testing System contains an optical verifier which works with the Meter to ensure the optical detection is working properly.

The Mission® Plus Hemoglobin (Hb) Control Solution is provided with 3 levels (0, 1, 2, ) of control solutions with known concentration of hemoglobin. It is used to confirm that the test meter and Test cartridges are working together properly. The product is a liquid, stable control prepared from bovine hemoglobin with added chemicals, preservatives (0.06%) and stabilizers (14.5% of sorbitol and sugar). The control does not contain products of human origins.

AI/ML Overview

The provided text describes the Mission® Plus Hemoglobin (Hb) Testing System and its comparison to a predicate device. Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing pass/fail acceptance criteria with numerical targets. However, the comparison table and discussion of tests performed imply the following performance aspects were evaluated for equivalence. The "Reported Device Performance" column synthesizes information from the various sections describing the device and its studies.

Acceptance Criteria (Implied)	Reported Device Performance (Mission® Plus Hb Testing System)
Accuracy (compared to predicate device / reference method)	Clinical studies at 4 sites showed "comparable blood Hemoglobin readings" to the predicate device. Laboratory studies included "Accuracy."
Linearity	Range: 4.5-25.6 g/dL (45-256 g/L, 2.8-15.9 mmol/L). Laboratory linearity study performed.
Precision	Laboratory precision study performed.
Reproducibility	Laboratory reproducibility study performed, including control precision and reproducibility.
Interference	Interference testing (CLSI EP7-A2) performed.
Electrical Safety & Electromagnetic Compatibility (EMC)	Found in compliance with IEC 61010-1, IEC 61010-2-101, FCC 47 CFR part 15, and EN 61326.
Ease of Use / User Satisfaction	Participants were "satisfied with the ease of operation by following the Instructions for Use in the User's Manual and the overall performance."
Effect of Sample Volume	Sample volume flexibility study performed.
Effect of Sample Storage Time	Sample storage time flexibility study performed.
Operating Temperature Performance	Operating temperature performance evaluated. Operating Conditions: 50 -104 °F (10 - 40 °C); ≤90% RH.
Meter Storage Temperature Performance	Meter storage temperature performance evaluated. Meter Storage Conditions: 32 -122 °F (0 - 50 °C); ≤90% RH.
Analytical Sensitivity	Analytical sensitivity study performed.
Hemoglobin (Hb) Control Value Assignment	Hemoglobin (Hb) control value assignment study performed.
Control Temperature Flexibility	Control temperatures flexibility study performed.
Product Stability (Accelerated and Real-time)	Product stability studies performed.
Safety and Reliability	Safety and Reliability Testing performed.
Low Battery Effect Evaluation	Low Battery Effect Evaluation performed.
Meter Environment Study	Meter Environment study performed.
Control Solution Environment Study	Control Solution Environment study performed.
Simulated Shipping Study (Test cartridge & Control Solution)	Simulated Shipping Study for Test cartridge and Control Solution performed.
Virucidal Efficacy Validation Testing	Virucidal Efficacy Validation Testing performed.
Meter's Cleaning and Disinfection	Meter's Cleaning and Disinfection study performed. Reference to FDA/CDC communications on fingerstick device use and EPA List D for antimicrobial products suggests consideration of cleaning/disinfection effectiveness against bloodborne pathogens.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated as a numerical value for the clinical study. It mentions clinical studies were conducted at "total 4 clinical sites." For non-clinical tests, specific sample sizes for linearity, precision, etc., are not provided.
Data Provenance:
- Clinical Studies: Conducted at "4 clinical sites" with "Health professionals at each site" operating the device. This suggests a prospective study involving patient samples. The country of origin is not specified but is likely the US given the FDA submission.
- Laboratory Testing: Performed as part of the "Non-Clinical Tests." The types of samples (e.g., patient, control) are not detailed for each test but generally involve various types of blood and control materials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide details on the number or specific qualifications of experts involved in establishing ground truth for the clinical studies. The "Health professionals at each site" operated the device, implying they are qualified to perform such tests, but their specific expertise in establishing ground truth or their experience levels are not mentioned.

4. Adjudication Method for the Test Set:

The document states that the "study data were presented for evaluating the system accuracy... compared to the results obtained from predicate device." This indicates a comparison study, but it does not specify an adjudication method (e.g., 2+1, 3+1). The "ground truth" was likely derived from the predicate device's readings or a reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was a MRMC study done? This type of study (MRMC) typically refers to evaluating multiple human readers' performance with and without a diagnostic aid on a set of cases. While the "clinical study" involved health professionals at multiple sites, it appears to be a direct comparison of the new device to the predicate device, with users' satisfaction also assessed. It is not presented as a MRMC study comparing human reader improvement with AI assistance. The device in question is a standalone hemoglobin testing system, not an AI-assisted diagnostic tool for interpretation by humans.
Effect Size of Human Readers with/without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance was done. The entire submission describes the performance of the Mission® Plus Hemoglobin (Hb) Testing System itself, which operates independently to measure hemoglobin. The clinical studies compare its results to a predicate device, and the laboratory tests evaluate its intrinsic analytical performance. The device is intended for "professional in vitro diagnostic use," meaning healthcare professionals utilize the device to get a result, but the device's reading is a direct measurement, not an AI output requiring human interpretation.

7. The Type of Ground Truth Used:

Clinical Studies: The ground truth for comparative accuracy in clinical studies was established by the predicate device (Hemopoint H2 Hemoglobin Measurement System, K032482). The study aimed to show "comparable blood Hemoglobin readings" to this predicate.
Non-Clinical (Laboratory) Tests: For calibration, it states "Factory calibrated against CLSI H15-A3 reference method," indicating a reference method was used for ground truth. For other analytical performance tests like linearity, precision, and analytical sensitivity, the ground truth would typically be derived from highly accurate reference measurements or known concentrations of control materials.

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of device development. This is a point-of-care medical device, not a machine learning or AI algorithm that typically has a distinct training phase with a specific dataset. Its calibration and performance are established through traditional analytical and clinical validation.

9. How the Ground Truth for the Training Set Was Established:

As there's no mention of a "training set" for an AI/ML algorithm, this question is not applicable. The device's foundational accuracy is rooted in its design, chemical reaction, and calibration against established reference methods (e.g., CLSI H15-A3).

Summary

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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 27, 2018

Acon Laboratories, Inc. Oiyi Xie Sr. Staff Regulatory/clinical Affairs 10125 Mesa Rim Road San Diego, California 92121

Re: K122553

Trade/Device Name: Mission Plus Hb Hemoglobin Testing System Regulation Number: 21 CFR 864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: Class II Product Code: GKR, GGM Dated: August 17, 2012 Received: August 21, 2012

Dear Qiyi Xie:

This letter corrects our substantially equivalent letter of August 5, 2013.

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.

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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 1000-1050.

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):

Device Name: Mission® Plus Hemoglobin (Hb) Testing System

Indications For Use:

The Mission® Plus Hemoglobin (Hb) Control Solution is intended to validate hemoglobin testing using the Mission® Plus Hemoglobin (Hb) Testing System.

The Mission® Plus Hemoglobin (Hb) Testing System is for professional in vitro diagnostic use only.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over - The - Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Leonthena R. Carrington -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k): K122553

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K122553

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §864.5620

The Assigned 510(k) number is

Submitter's Identification:

ACON Laboratories, Inc.

10125 Mesa Rim Road

San Diego, California 92121

Tel.: 858-875-8019 Fax: 858-875-8099

Date Prepared: August 2, 2013

Contact Person:

Qiyi Xie Senior Staff, Clinical & Regulatory Affairs

Proprietary Name of the Device:

Mission® Plus Hemoglobin (Hb) Testing System Mission® Plus Hemoglobin (Hb) Control Solution

Common Name:

Automated hemoglobin system

Regulatory Information:

Regulation section: 21 CFR 864.5620, Automated hemoglobin system 21 CFR 862.1660, Quality control material (assayed and unassayed) 2. Classification: Class II & I 3. Product Code: GKR, JJX 4. Panel: Hematology (81)

Predicate Device(s):

Hemopoint H2 Hemoglobin Measurement System, Stanbio Laboratory 1261 North Main Street, Boerne, Texas 78006 510(k) Number: K032482

AUG 0 5 2013

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Proprietary Name	Classification	ProductCode	Description	Common Name
Mission® PlusHemoglobin (Hb)Testing System	Class II§864.5620	GKR	System, Test,Hemoglobin TestSystem,	HemoglobinTest Meter
Mission® PlusHemoglobin (Hb)Control Solution	862.1660Class I	JJX	Analyte Control	Control Solution

Device Name: Mission® Plus Hemoglobin (Hb) Testing System

Device description:

The Mission® Plus Hemoglobin Testing System consists of The Mission® Hemoglobin (Hb) Testing Meter, Test cartridge, Control Solutions, and Optical Verifier.

The Mission® Plus Hemoglobin (Hb) Testing System contains an optical verifier which works with the Meter to ensure the optical detection is working properly.

Intended Use:

The Mission® Plus Hemoglobin (Hb) Testing System is for the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA (K2, K3, Na2) or sodium heparin. The testing system is designed for pointof-care use in primary care settings. Estimation of hematocrit is only for hemoglobin values from 12.3 to 17.5 g/dL (123 to 175 g/L).

The Mission® Plus Hemoglobin (Hb) Control Solution is intended to validate hemoglobin testing using the Mission® Plus Hemoglobin (Hb) Testing System.

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The Mission® Plus Hemoglobin (Hb) Testing System is for professional in vitro diagnostic use only.

Features	Specifications
Methodology	Reflectance Photometer
Test Time	<15 seconds
Measurement Range	4.5-25.6 g/dL, 45-256 g/L, 2.8-15.9 mmol/L
Specimen	Whole blood
Specimen Volume	10 µL
	4 AAA batteries (1.5 V)
Power Source	AC Adapter (Mini USB, 5V dc, 50 mA) - Not included
Battery Life	360 hours or 2,700 tests
Units of Measure	g/dL, g/L, mmol/L
Memory	1,000 records
Automatic Shut Off	8 minutes after last action
Meter Size	5.4" × 3.11" ×1.02" (137 mm × 79 mm × 26 mm)
Display Size	1.97" ×1.97" (50 mm × 50 mm)
Weight	145g (without batteries)
Meter Storage Conditions	32 -122 °F (0 - 50 °C); ≤90% RH
Operating Conditions	50 -104 °F (10 - 40 °C); ≤90% RH
Meter Connectors	USB cable for Data Transfer or Power (optional)
Methodology	Reflectance Photometer

Technological Characteristics and Substantial Equivalence: Specification of Blood Hemoglobin Meter:

Comparison to Predicate Device:

The Mission® Plus Hemoglobin (Hb) Testing System and the predicate device are all intended for the quantitative measurement of total hemoglobin in samples of whole blood. No sample preparation or reagents are required. The Mission® Plus Hemoglobin (Hb) Testing System is substantially equivalent to Hemoglobin Measurement System, K032482.

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Device Comparison Table

Similarities
Features	Device	Predicate (K032482)
Intend Use	The Mission® Plus Hemoglobin (Hb)Testing System is for the quantitativedetermination of hemoglobin in non-anticoagulated capillary whole blood oranticoagulated venous whole blood in EDTA(K2, K3, Na2) or sodium heparin. Thetesting system is designed for point-of-careuse in primary care settings. Estimation ofhematocrit is only for hemoglobin valuesfrom 12.3 to 17.5 g/dL (123 to 175 g/L).The Mission® Plus Hemoglobin (Hb)Control Solution is intended to validatehemoglobin testing using the Mission® PlusHemoglobin (Hb) Testing System.The Mission® Plus Hemoglobin (Hb)Testing System is for professional in vitrodiagnostic use only.	The HemoPoint H2 HemoglobinMeasurement System is indicated for thequantitative determination ofhemoglobin in arterial, venous, orcapillary blood.The microcuvettes part number 3010-100are indicated for use in the HemoPointBH2 Hemoglobin Measurement System andthe HemocueB measurement system.The microcuvettes are intended to be usedonly once and must be disposed of afteruse as potentially infectious waste.Estimation of hematocrit as a function ofHemoglobin is performed for normalhemoglobin ranges only (120to 180 g/L or 12.0 to 18.0 g/dL). Theestimated hematocrit is not indicative ofdisease states such as anemia andabnormal values and will not be reported.
Test DetectionPrinciple	Quantitative Reflectance Photometer formeasurement of hemoglobin	Same
Visual Display	LCD readout	Same
Calibration	Factory calibrated against CLSI H15-A3reference method	Same
Recommendtestingenvironment	Doctors' offices	Same
Similarities
Features	Device	Predicate (K032482)
Controls	3 levels (0, 1, 2,) of control solutions preparedfrom bovine hemoglobin with addedchemicals, preservatives (0.06%) andstabilizers (14.5% of sorbitol and sugar). Thecontrol does not contain products of humanorigins and may be used for up to 30 daysstored at 35°-46°F after opening.	A bi-level reference control set intendedfor use on Alere HemoPoint® H2 System.Bi-levels (High and Low) of hemoglobincontrols are made from animal bloodbovine based materials, in reliable liquidform may be used for up to 60 days ifstored at 35°-46°F, or 30 days stored atroom temperature after opening.
Quality ControlRequirements	Users are directed to perform daily opticalelectronic verification testing and liquidcontrol testing: with each new shipment and/orlot of Test cartridges, or when test results aresuspect	Users are directed to perform dailyelectronic quality control testing andliquid control testing: with each newshipment and/or lot of Test cartridges, orwhen test results are suspect
Units ofMeasure	g/dL, g/L, mmol/L	Same
Differences
Features	Device	Predicate (K032482)
Test Time	≤15 seconds10 - 60 seconds	Approximately 30-60sec
Assay Method	Methemoglobin method(Erythrocytes in the specimen are lysed torelease hemoglobin by the action of sodiumdexycholate. Then the hemoglobin is convertedto methemoglobin by the action of sodiumnitrite. The intensity of the color producedfrom this reaction is proportional to thehemoglobin concentration.)	Azidemethemoglobin method (Vanzetti)Hematocrit (Hct)=estimation fromhemoglobin
MeasurementRange	4.5-25.6 g/dL,(2.8-15.9 mmol/L)	0-25.6 g/dL,(0-15.9 mmol/L)
Specimen	Capillary and venous whole blood	Venous, arterial, or capillary blood
SpecimenVolume	10 µL	8 µL
Memory	1,000 records	Up to 4,000 records
MeterConnectors	USB (mini) cable for Data Transfer or Power(optional)	No computer connector, only cable forconnecting to a specific printer throughcox cable. No Data Transfer.
Power supply	AC Power adaptor:Input: 100-240V AC/50-60HzOutput: 5V DC, 50mA4AAA batteries:Voltage: 6.0V	AC Power adaptor:Input: 100-250V AC/50-60HzOutput: 6V DCIntegrated battery:Voltage:2.4VCapacity: 1500mAh
Automatic ShutOff	8 minutes after last use	5 minutes after last use
Meter Size	3.1" ×5.4" × 1"(79×137×26mm)(159 x 165 x 63.5mm)	3.35" × 6.3" × 1.69"(85×160×43mm)
Display Size	2" ×2"(50 mm × 50 mm)2.25" x 1.25" (57.15 x 31.75mm)	2.19" × 0.81" (21 mm × 55mm)
Weight	0.41 pounds (188g) (with batteries)1.3	0.77 pounds (350g) (with batteries)
Environmentaltemperature	50 - 104 °F (10 - 40 °C); less than 90% relativehumidity (without condensation)	59-86°F (15-30°C), less than 79% relativehumidity (without condensation).

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Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The Mission® Plus Hemoglobin (Hb) Testing system underwent electrical safety testing and electromagnetic compatibility testing and was found to be in compliance with applicable

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requirements of IEC 61010-1, IEC 61010-2-101, FCC 47 CFR part 15, and EN 61326. Other Non-Clinical Tests Performed for SE are:

1. H3-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture: Approved Standard-Fourth Edition, CLSI.
1. H4-A4 Procedures and Devices for the Collection of Diagnostic Blood Specimens by Skin Puncture; Approved Standard-Fourth Edition, CLSI.
1. H15-A3 Reference and Selected Procedures for the quantitative Determination of Hemoglobin in Blood: Approved Standard-Third Edition, CLSI.
1. EP09-A2 Method comparison and Bias Estimation Using Patient Samples; Approved Standard-Second Edition, CLSI.
1. EP05-An Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline, CLSI.
CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement 6. Procedures: A Statistical Approach.
1. H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
CLSI H26A Performance Goals for the Internal Quality Control of Multichannel 8. Hematology Analyzers; Approved Standard, H26-A
1. CLSI EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline -Second Edition.
1. FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication (2010)
1. CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk or Transmitting Bloodborne Pathogens (2010)
1. US Environmental Protection Agency Office of Pesticide Programs. List D: EPA's Registered Antimicrobial Products Effective Against Human HIV-1 and Hepatitis B Virus (January 9, 2009)

Laboratory Testing:

The performance characteristics of The Mission® Plus Hemoglobin (Hb) Testing System were evaluated by performing the following studies: Linearity, Precision, Reproducibility, Accuracy, Interference. Sample volume flex. Sample storage time flex. Operating temperature, Meter Storage temperature, Analytical sensitivity, Hemoglobin (Hb) control value assignment, Control temperatures flex study, Control precision and reproducibility studies, Product stability, (Accelerated and Real time), Safety and Reliability Testing, Low Battery Effect Evaluation, Meter Environment study, Control Solution Environment study, Simulated Shipping Study - Test cartridge, Simulated Shipping Study - Control Solution, Virucidal Efficacy Validation Testing and Meter's Cleaning and Disinfection.

Discussion of Clinical Tests Performed:

Clinical studies were conducted at total 4 clinical sites using the Mission® Plus Hemoglobin (Hb) Testing System in comparison with predicate device. Health professionals at each site operated the device and the study data were presented for evaluating the system accuracy of The Mission® Plus Hemoglobin (Hb) Testing System compared to the results yielded from

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predicate device per the ACON Clinical Study Protocol for the Blood Hemoglobin Monitoring System. Study results indicate that intend users were able to obtain comparable blood Hemoglobin readings when using the Mission® Plus Hemoglobin (Hb) Testing System as compared to the results obtained from predicate device. In addition, the participants were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User's Manual and the overall performance of the Mission® Plus Hemoglobin (Hb) Testing System.

Conclusion:

The laboratory testing and clinical study results demonstrate that The Mission® Plus Hemoglobin (Hb) Testing System is safe, effective and easy-to-use. It also demonstrates that The Mission® Plus Hemoglobin (Hb) Testing System is substantially equivalent to the Hemopoint H2 Hemoglobin Measurement System, 510(k) Number: K032482, currently sold on the U.S. market.

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).