Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated and manual methods of reticulocyte counting.

Device Description

Retic-Chex for Cell-Dyn is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials containing 1.0ml volumes. The device consists of two levels of reticulocyte percentage range. Control I reticulocyte percent range will be 1.5 - 2.0. Control II reticulocyte percent range will be 3.9 - 5.8. Closures are injection molded polypropylene screw-top caps. The vials are packaged in vacuum molded clam-shell box.

AI/ML Overview

The provided text is a 510(k) summary for Retic-Chex for Cell-Dyn, a hematology control device. It describes the device, its intended use, and states that three studies were conducted to demonstrate its performance. However, the document does not explicitly state acceptance criteria in a quantitative manner, nor does it provide detailed quantitative results that would typically be reported as "reported device performance." Instead, it broadly concludes that the device is "consistently reproducible and stable."

Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific numerical values as this information is not present in the provided text.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated quantitatively in the document)	Reported Device Performance (Summary from document)
Device to be consistently reproducible	Study results showed Retic-Chex for Cell-Dyn to be consistently reproducible.
Device to be stable for the entire product dating	Study results showed Retic-Chex for Cell-Dyn to be stable for the entire product dating.
Substantially equivalent to predicate product	Study results show Retic-Chex for Cell-Dyn to be substantially equivalent to the predicate product (Retic-Chex Linearity, K000115).
Fulfills intended use when used as instructed	Retic-Chex for Cell-Dyn is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.

2. Sample size used for the test set and the data provenance:

Sample size for the test set: Not explicitly stated. The document mentions "Three studies... were conducted," but does not provide details on the number of samples or measurements within each study.
Data provenance: Not explicitly stated. The studies were conducted by Streck Laboratories, Inc., presumably at their facilities. No information about the country of origin of the data or whether it was retrospective or prospective is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a quality control material for automated reticulocyte counting. Its "ground truth" (or target values) would be established through a rigorous assay process using reference methods and potentially multiple instruments/operators, rather than expert interpretation of images or clinical cases. The document does not describe the specific method used to establish the "ground truth" for the control levels, other than stating it is an "assayed control."

4. Adjudication method for the test set:

Not applicable. Given the nature of the device as a quality control material, rather than a diagnostic tool requiring interpretation of complex data (e.g., images), an adjudication method as typically understood for expert consensus is not relevant or described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a control material for laboratory instruments, not an AI-powered diagnostic system that assists human readers in interpreting clinical cases. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a reagent/control material; it is not an algorithm or a standalone diagnostic system.

7. The type of ground truth used:

The device is described as an "assayed control". This implies that the "ground truth" (the target reticulocyte percentage ranges for Control I and Control II) would have been established through analytical testing and validation using reference methods and/or the intended automated reticulocyte counters. The document specifies reticulocyte percentage ranges for Control I (1.5 - 2.0%) and Control II (3.9 - 5.8%), which serve as the "ground truth" or expected values for the control material.

8. The sample size for the training set:

Not applicable. As this is a quality control material and not a machine learning algorithm, there is no "training set" in the context of AI/ML development. The studies performed ("Closed Vial Stability," "Open Vial Stability," and "Manual Count Closed Vial Stability") are for product validation, not algorithm training.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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K042587

510(k) Summary of Safety and Effectiveness

510(k) Submitter: Streck Laboratories 7002 South 109th Street La Vista, NE 68128

Official Correspondent: Carol Thompson, Quality Assurance Manager (402) 537-5313

September 17, 2004 Date Prepared:

Names of Device:
Trade Name:	Retic-Chex for Cell-Dyn®
Common Name:	Hematology Reagents
Classification Name:	Hematology quality control mixture, 21CFR864.8625
Predicate Device:	Retic-Chex® Linearity manufactured by Streck Laboratories, K000115

Description:

Intended Use:

Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated, and manual methods of reticulocyte counting. It is designed for use on the following automated reticulocyte counting. It is designed for use on the following reticulocyte analyzers: Abbott Cell-Dyn 4000, 3700, 3500, and 3200,

Comparison with Predicate Device:

Like Retic-Chex Linearity, Retic-Chex for Cell-Dyn is a multi-level device intended for validation of reticulocyte analysis on a variety of automated hematology instruments. Both devices contain stabilized human red blood cells and simulated human reticulocytes, which properly mimic human whole blood on the intended use analyzers.

Testing Performed:

Three studies of Retic-Chex for Cell-Dyn were conducted: 1) Closed Vial Stability: 2) Open Vial Stability; and 3) Manual Count Closed Vial Stability. Study results showed Retic-Chex for Cell-Dyn to be consistently reproducible and stable for the entire product dating.

Conclusions Drawn from the Tests:

Study results show Retic-Chex for Cell-Dyn to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. Retic-Chex for Cell-Dyn is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.

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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine. The caduceus in the logo is depicted with three intertwined strands.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 9 2004

Ms. Kerrie Oetter Quality Assurance Coordinator Streck Laboratories, Inc. 7002 South 109th Street La Vista, NE 68128

Re: K042587

Trade/Device Name: Retic-Chex for Cell-Dyn® Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: September 17, 2004 Received: September 22, 2004

Dear Ms. Oetter:

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 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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker, Jr.

Robert L. Becker, Jr., M.D., 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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510(k) Number (if known):

K042587

Device Name: Retic-Chex for Cell-Dyn®

Indications For Use:

Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated and manual methods of reticulocyte counting.

Prescription Use_X_ (Per 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 Diagnostic Devices (OIVD)

Josephine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD42587

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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.