WBC (108/L), RBC (1013L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10°/L), MPV (iL), NEU (%), NEU (10°/L), LYM (%), LYM (10°/L), MON (10°/L), EOS (%),
EOS (10°/L), BAS (%), BAS (10°/L)

Device Description

CELL-DYN 22 Plus Control is an in-vitro diagnostic product that contains stabilized human red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium. The product is packaged in polypropylene plastic vials containing 2.5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CELL-DYN 22 Plus Control, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document implicitly defines "acceptance criteria" through the types of studies conducted and the conclusions reached. It doesn't present a table with specific numerical thresholds for acceptance for each parameter (e.g., "WBC reproducibility must be within X% CV"). Instead, it states the overall goals and then concludes that the device met these goals.

Here's an interpretation of the implied acceptance criteria and the reported performance:

Acceptance Criteria (Implied)	Reported Device Performance
Consistently reproducible performance	"consistently reproducible"
Substantially equivalent to predicate device (Para 12 Plus)	"substantially equivalent to the predicate product"
Stable for the claimed shelf life (closed vial)	"stable for the entire product dating"
Stable for the claimed shelf life (open vial)	"stable for the entire product dating"
Fulfills intended use for accuracy and precision on CELL-DYN Emerald 22 system	"fulfills its intended use when used as instructed"

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

Sample Size: The document does not explicitly state the total number of samples or runs for each specific test (e.g., how many vials for closed-vial stability, how many individual tests for reproducibility).
- 10-Run Reproducibility: This indicates that at least 10 runs were performed for this specific test.
- External Site Recovery: No specific sample size is provided for this.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a medical device submission, it's highly likely the studies were prospective, conducted specifically for this submission.

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

This information is not applicable to this type of device (hematology control). Hematology controls are assayed products, meaning their expected values are pre-determined through precise laboratory measurements and statistical analysis, not through expert consensus like image interpretation. There were no "experts" establishing a ground truth in the sense of clinical interpretation.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like '2+1' or '3+1' are used when there's subjective interpretation involved, typically in clinical studies or image analysis where multiple readers evaluate cases and discrepancies need to be resolved. For a hematology control, performance is measured against pre-established assayed values or against the performance of a predicate device, not by expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and assessing how AI assistance impacts their performance. The CELL-DYN 22 Plus Control is a quality control material for an automated hematology analyzer, not a diagnostic tool requiring human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not directly applicable in the context of this device. The CELL-DYN 22 Plus Control is a control material that is run on an automated analyzer. Its "performance" is how reliably it produces expected results on that analyzer. The device itself does not have an "algorithm" in the sense of an AI or diagnostic tool. The performance of the control is evaluated by measuring its values (e.g., WBC, RBC) on the CELL-DYN Emerald 22 system, which is an automated process. The "standalone" performance here would refer to the consistency and accuracy of the control material in isolation, which is what the stability and reproducibility studies aimed to demonstrate.

7. The Type of Ground Truth Used

The "ground truth" for the CELL-DYN 22 Plus Control is established by its assayed values. These values are determined through rigorous laboratory testing on reference instruments or using validated methods, and then likely subjected to statistical analysis to establish expected ranges for each parameter (e.g., WBC, HGB, PLT) for the low, normal, and high control levels. The performance of the control is then assessed by comparing the results obtained on the target instrument (CELL-DYN Emerald 22) to these predetermined assayed values and predicate product performance.

8. The Sample Size for the Training Set

This product does not have a "training set" in the context of machine learning or AI algorithms. It is a physical control material. Its "development" phase would involve formulating the material and then performing extensive testing (as described in the studies) to validate its stability, reproducibility, and assayed values.

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

As there is no "training set" for this product, this question is not applicable. The ground truth (assayed values) for the control material itself is established through internal laboratory characterization and validation studies, often involving multiple runs on reference instruments and statistical analysis to determine the target ranges for each parameter.

Summary

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510(k) Summary of Safety and Effectiveness

DEC 2 2 2011

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128
Official Correspondent:	Bert Moses, Director of Quality(402)537- 5343
Date Prepared:	April 14, 2011
Name of Device:Trade Name:Common Name:Classification Name:	CELL-DYN 22 Plus ControlAssayed Hematology ControlHematology quality control mixture (864.8625)
Predicate Device:	Para 12 Plus (K901875) Manufactured by Streck

Description:

Intended Use:

CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system.

Assayed parameters include:

	Para 12 Plus (Predicate Product)	CELL-DYN 22 Plus Control
Intended UseStatement	Para 12 Plus is an assayedhematology control for evaluatingthe accuracy and precision ofhematology instruments that providea white blood cell differential.	CELL-DYN 22 Plus Control is anassayed hematology control forevaluating the accuracy and precisionof the CELL-DYN Emerald 22 system.Assayed parameters include:$WBC (10^9/L), RBC (10^{12}/L), HGB$(g/dL), HCT (%), MCV (fL), MCH (pg),MCHC (g/dL), RDW (%), PLT $(10^9/L)$ ,MPV (fL), NEU (%), NEU $(10^9/L)$ , LYM(%), LYM $(10^9/L)$ , MON (%), MON$(10^9/L)$ , EOS (%), EOS $(10^9/L)$ , BAS(%), BAS $(10^9/L)$
Open Vial Stability	7 days	8 days
Closed Vial Stability	75 days	Same

Comparison to Predicate Device:

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Reagents	The whole blood reagent maycontain any or all of the following:stabilized human or mammalian redblood cells, human, mammalian orsimulated white blood cells and aplatelet component in a preservativemedium.	Same
Storage Conditions	2 - 10°C	Same

Discussion of Tests and Test Results:

Five types of studies were conducted to establish performance of CELL-DYN 22 Plus Control. The five tests conducted were Closed-Vial Stability, Open-Vial Stability, 10-Run Reproducibility, 10-Run Reproducibility compared with Whole Blood and External Site recovery of values. All testing showed that CELL-DYN 22 Plus Control is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.

Conclusions Drawn From Tests:

Study results show CELL-DYN 22 Plus Control to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. CELL-DYN 22 Plus Control 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/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 or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Streck Inc. c/o Ms. Deborah S. Kipp Quality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128

DEC & 2 2011

Re: K111211

Trade/Device Name: CELL-DYN 22 Plus Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GLQ Dated: December 21, 2011 Received: December 22, 2011

Dear Ms. Kipp:

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. Deborah Kipp

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/ReportaProblem/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,

.maria mchen

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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Indication for Use Form

510(k) Number (if known):

K///2//

Device Name: CELL-DYN 22 Plus Control

Indications For Use:

CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system.

Assayed parameters include:

WBC (108/L), RBC (1012/L), HGB (g/dL), HCT (%), MCV (pg), MCHC (g/dL), RDW (%), PLT (10%L), MPV (fL), NEU (%), NEU (10%L), LYM (%), LYM (109%), MON (108%), EOS (%), EOS (10°/L), BAS (%), BAS (10°/L)

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)

m. Chen

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111211

Page 1 of 1

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.