The R&D Systems Retic-I Plus Hematology Control is an in vitro diagnostic reagent composed of human and avian erythrocytes in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring automated reticulocyte counting method. It is sampled in the same manner as a patient specimen.

AI/ML Overview

Here's an analysis of the provided text regarding the R&D Systems Retic-I Plus Hematology Control, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Remaining within assay range over product life	"The Retic-I Plus Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product."
Expiration dating (closed vial)	Established at 75 days when stored at 2 - 8° C.
Expiration dating (open vial)	Established at 14 days when stored at 2 - 8° C.
Performance	"substantial equivalence in performance... to the predicate device."
Precision	"substantial equivalence in... precision... to the predicate device."
Stability	"substantial equivalence in... stability to the predicate device."

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

Sample Size: The document states that "Laboratory testing of 3 validation lots has shown..." This indicates a test set size of 3 lots of the Retic-I Plus Hematology Control.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but the nature of device validation testing generally implies a prospective study design where the device is tested under controlled conditions.

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

This information is not provided in the document. The study appears to be a laboratory validation of a control material against a predicate device, rather than a clinical study requiring expert assessment of individual cases. The ground truth for a hematology control would typically be established by precise measurements using well-calibrated reference methods or instruments, not by human expert consensus on specific cases.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess cases and discrepancies need to be resolved. This study focuses on the performance, precision, and stability of a laboratory control material.

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

Was it done?: No. The document describes a laboratory validation study comparing the new control material's performance to a predicate device, not a human reader study evaluating the effectiveness of AI assistance.
Effect size of human reader improvement with AI vs. without AI assistance: This information is not applicable as an MRMC study was not performed.

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

Was it done?: Yes, in essence. The study described focuses on the inherent performance of the Retic-I Plus Hematology Control as a standalone product. While it's not an "algorithm" in the typical AI sense, the control material itself is the "device" being evaluated for its performance characteristics (stability, precision, staying within assay range) independent of human interpretation of individual patient samples. The performance described ("remaining within the assay range over the life of the product," "substantial equivalence in performance, precision and stability") refers to the intrinsic behavior of the control.

7. Type of Ground Truth Used

The ground truth used for this device appears to be based on:

Assay Range: The acceptable range of values for reticulocyte counts that the control should maintain. These ranges would likely be established through rigorous laboratory testing on reference instruments or methods.
Predicate Device Performance: The established, known performance (stability, precision) of the legally marketed predicate device (R&D Systems Advia Retic Plus Hematology Control). The new device's performance is compared against this established benchmark to demonstrate "substantial equivalence."

8. Sample Size for the Training Set

This information is not provided and is not applicable for this type of device. Hematology control materials are not "trained" in the way an AI algorithm is trained. Their performance characteristics are inherent to their formulation and manufacturing process, which are then validated through testing.

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

This information is not provided and is not applicable for this type of device, as there is no "training set" in the context of an AI algorithm learning from data. The properties of the control material (e.g., stability, assay range) are determined intrinsically and validated experimentally.

Summary

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KO91433

510(k) Summarv

Submitter Information

R&D Systems. Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Contact: Nancy Ring Phone: 612-656-4533 Fax: 612-379-6580 Date Prepared: 10/05/09

OCT 2 8 2009

Device Information

Proprietary Name: Common Name: Classification Classification Name: Product Code: Device Class: Panel:

Retic-I Plus Hematology Control Hematology Controls 21 CFR 864.8625 Hematology Quality Control Mixture JPK = Hematology (81)

Predicate Device

R&D Systems Advia Retic Plus Hematology Control, (K010461) manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413.

Description of Device

Intended Use:

R&D Retic-I Plus Control is a tri-level, assayed hematology control designed to monitor values obtained from automated reticulocyte counting methods.

Technological Comparison to Predicate

The new device has the same technological characteristics as the legally marketed predicate device. Both are used to perform quality control assays and both products are used to monitor values obtained from automated reticulocyte counting methods. The R&D Retic-1 Plus Hematology Control is assayed for additional parameters.

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Summary of Performance Data

Laboratory testing of 3 validation lots has shown the R&D Retic-I Plus Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The Retic-I Plus Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. Expiration dating will be established at 75 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C and handled according to instructions for use.

Substantial Equivalence Conclusion

The data demonstrate that the R&D Retic-I Plus Hematology Control is substantially equivalent to the legally marketed predicate 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 stylized eagle with three tail feathers, representing the department's commitment to promoting health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

R & D Systems, Inc c/o Ms. Nancy Ring Sr. Quality Assurance/Regulatory Affairs Specialist 614 McKinley Place, N.E. Minneapolis, MN 55413

OCT 2 8 2009

Re: K091433

Trade/Device Name: R&D Systems Retic-I Plus Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: September 16, 2009 Received: September 17, 2009

Dear Ms. Ring:

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.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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Page 2 - Ms. Ring

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

m. Chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices 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): ____________________________________________________________________________________________________________________________________________________

Device Name: R&D Retic-1 Plus Hematology Control

Indications for Use:

R&D Retic-I Plus Control is a tri-level, assayed hematology control designed to monitor values obtained from automated reticulocyte counting methods.

For in vitro Diagnostic Use Only

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) 091433

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.