(349 days)
Not Found
No
The description focuses on optical measurement of color intensity and standard laboratory and clinical performance studies, with no mention of AI or ML.
No.
The device is for quantitative determination of hemoglobin, which is a diagnostic function, not a therapeutic one. Therapeutic devices are used for treatment or prevention of disease.
Yes
The device is explicitly stated as being "for professional in vitro diagnostic use only" and performs "quantitative determination of hemoglobin," which is a diagnostic measurement.
No
The device description explicitly lists hardware components such as a meter, test cartridges, control solutions, and an optical verifier.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Mission® Plus Hemoglobin (Hb) Testing System is for professional in vitro diagnostic use only."
- Nature of the Test: The device performs a quantitative determination of hemoglobin in blood samples. This is a laboratory test performed outside of the body (in vitro) to diagnose or monitor a medical condition.
- Components: The system includes a meter, test cartridges, and control solutions, which are typical components of an IVD system used for analyzing biological samples.
- Intended Use: The intended use is for point-of-care use in primary care settings by professionals, which aligns with the use of IVD devices for clinical decision-making.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
GKR, JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The testing system is designed for point-of-care use in primary care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 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.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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 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.
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 1000-1050.
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) 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.
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
3
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
4
| Proprietary Name | Classification | Product
Code | Description | Common Name |
|------------------------------------------------------|-----------------------|-----------------|---------------------------------------------|--------------------------|
| Mission® Plus
Hemoglobin (Hb)
Testing System | Class II
§864.5620 | GKR | System, Test,
Hemoglobin Test
System, | Hemoglobin
Test Meter |
| Mission® Plus
Hemoglobin (Hb)
Control Solution | 862.1660
Class 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 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.
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.
5
The Mission® Plus Hemoglobin (Hb) Testing System is for professional in vitro diagnostic use only.
| Features | Specifications | |
|---|---|---|
| Methodology | Reflectance Photometer | |
| Test Time |