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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ABX ERYTROL device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Remaining within the assay range over the life of the product (stability)	ABX Erytrol stayed within the assay range. Expiration dating established at 60 days in customer's hands (closed vial) and 10 days or 12 entries (open vial) when stored at 2-8°C and handled according to instructions.
Precision (demonstrated by small standard deviations and % CV)	ABX Erytrol demonstrated precision as indicated by the small standard deviations and % CV obtained during testing.

Study Details

Sample size used for the test set and the data provenance: Not explicitly stated. The study refers to "3 validation lots." The country of origin for the data is France, where the company Horiba ABX is located. The study appears to be non-clinical, likely laboratory-based testing rather than clinical trials with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not stated. As this is a quality control material rather than a diagnostic device that interprets patient data, expert review for ground truth isn't relevant in the traditional sense. The "ground truth" for a quality control material is its expected assay range and stability performance, which is determined by the manufacturer's internal testing and specifications.
Adjudication method for the test set: Not applicable/not stated.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not applicable for a hematology quality control mixture.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the testing described appears to be standalone performance testing of the quality control material itself and its interaction with ABX hematology analyzers.
The type of ground truth used: Manufacturer's internal specifications and expected performance characteristics for stability and precision against an assay range. This is derived from thorough development and testing of the control material.
The sample size for the training set: Not applicable/not stated. For a quality control mixture, there isn't a "training set" in the machine learning sense. The formulation and initial characterization of the control would involve extensive developmental testing, but specific "training set" sizes are not relevant here.
How the ground truth for the training set was established: Not applicable/not stated for a "training set." The performance characteristics (e.g., assay range, expected stability, precision limits) are established through extensive R&D and manufacturing processes, including characterization of the components and the final product's behavior over time and under various conditions.

Summary

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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.

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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 :

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.

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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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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
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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)
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Josephine Bautista
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

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Regulation Number and Section

§ 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.