(72 days)
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No
The document describes an in-vitro diagnostic blood control used for monitoring the accuracy of hematology analyzers. There is no mention of AI or ML in the intended use, device description, or performance studies. The device is a stable material for quality control, not a software or algorithm-based diagnostic tool.
No
The device is described as an "in-vitro diagnostic blood control" used for monitoring the accuracy and precision of hematology blood cell counters. It is not used to treat, diagnose, or prevent disease in a patient.
No
Explanation: The device is an in-vitro diagnostic blood control used for monitoring the performance of hematology analyzers, not for diagnosing diseases in patients. It helps ensure the accuracy of other diagnostic devices.
No
The device is an in-vitro diagnostic blood control, which is a physical substance used to monitor the performance of a hematology analyzer. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "for use in monitoring the accuracy and precision of the HoribaABX hematology blood cell counters for the nucleated red blood cell count (NRBC parameter)." This is a diagnostic purpose – assessing the performance of an instrument used to diagnose conditions based on blood analysis.
- Device Description: The description states it's an "in-vitro diagnostic blood control." This directly identifies it as an IVD.
- Composition: It's composed of biological materials (human erythrocytes & mammalian leukocytes) in a fluid, which is typical for in-vitro diagnostic reagents and controls.
- Function: It's used to monitor the performance of a diagnostic instrument (hematology analyzer). This is a key function of an IVD control.
Therefore, based on the provided information, the ABX Erytrol is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ABX Erytrol is a tri-level control design for use in monitoring the accuracy and precision of the HoribaABX hematology blood cell counters for the nucleated red blood cell count (NRBC parameter). Refer to the assay table for specific instrument models.
Product codes
JPK
Device Description
The ABX Erytrol is an in-vitro diagnostic blood control composed of human erythrocytes & mammalian leukocytes in a plasma-like fluid with preservatives.
The ABX Erytrol is composed of stable materials that provide a means of monitoring the performance of ABX hematology analyzers offering the nucleated red blood cell count (NRBC) parameter.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ABX Erytrol underwent non clinical testing of 3 validation lots centered on the performance attributes of stability and precision, passing the acceptance criteria of remaining within the assay range over the life of the product. ABX Erytrol also demonstrated precision as indicated by the small standard deviations and % CV obtained during testing.
Expiration dating has been established at 60 days in the customers hands (closed vial) and 10 days, or 12 entries, open vial when stored at 2-8°C and handled according to instructions for use.
All non clinical tests show appropriate levels of safety and effectiveness for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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JUN 1 - 2005
Premarket Notification [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 807.92
The assigned 510(k) number is: K050721
Company: Horiba ABX
Parc Euromédecine
Rue du Caducée – BP 7290
34184 Montpellier cedex 4
FRANCE
Telephone: + (33) 4 67 14 73 20
Fax: + (33) 4 67 14 15 17
Contact Person: Tim Lawton (tlawton@fr.abx f
Contact Person: Tim Lawton (tlawton@fr.abx.fr)
Date Prepared: 14th March 2005
Device Name:
| Trade/Proprietary Name: | ABX ERYTROL |
|---|---|
| Common or Usual Name: | Hematology Quality Control Mixture counter |
| Device Class | Class II : Hematology Device |
| Classification Name: | AutoHematology Quality Control Mixture |
| Product Code: | JPK |
Substantial Equivalence:
The ABX Erytrol is substantially equivalent to another hematology blood control of the PENTRA 5D Hematology control approved by R& D Systems Inc under the submission K003534.
1
Description:
The ABX Erytrol is an in-vitro diagnostic blood control composed of human erythrocytes & mammalian leukocytes in a plasma-like fluid with preservatives.
The ABX Erytrol is composed of stable materials that provide a means of monitoring the performance of ABX hematology analyzers offering the nucleated red blood cell count (NRBC) parameter.
Intended Use :
ABX Erytrol is a tri-level control design for use in monitoring the accuracy and precision of the HoribaABX hematology blood cell counters for the nucleated red blood cell count (NRBC parameter). Refer to the assay table for specific instrument models.
Determination of substantial equivalence :
ABX Erytrol has an intended use that is identical to the predicate device for use in monitoring the accuracy and precision. The technologies of the two devices are identical.
Discussion of Performance Data:
ABX Erytrol underwent non clinical testing of 3 validation lots centered on the performance attributes of stability and precision, passing the acceptance criteria of remaining within the assay range over the life of the product. ABX Erytrol also demonstrated precision as indicated by the small standard deviations and % CV obtained during testing.
Expiration dating has been established at 60 days in the customers hands (closed vial) and 10 days, or 12 entries, open vial when stored at 2-8°C and handled according to instructions for use.
All non clinical tests show appropriate levels of safety and effectiveness for this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure with three wavy lines emanating from the head, resembling hair or energy.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Tim Lawton Regulatory Affairs Manager HORIBA ABX Diagnostics Parc Euromedecine Rue Du Caducee - BP 7290 34184 Montpellier cedex 4 FRANCE
Re: K050721
Trade/Device Name: ABX ERYTROL Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: II Product Code: JPK Dated: April 29, 2005 Received: May 9, 2005
Dear Mr. Lawton:
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. 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.
JUN 1 - 2005
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K050721 |
|---|---|
| --------------------------- | --------- |
Device Name:__________ABX ERYTROL
Indications For Use:
ABX Erytrol is a tri-level control designed for use in monitoring the accuracy and precision of the HoribaABX hematology blood cell counters for NRBC parameter. Refer to the assay table for specific instrument models.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Josephine Bautista
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
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