CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system. Assayed parameters include: WBC (109/L), RBC (1012/L), HGB (g/dL), MCV (fL), PLT (109/L)

Device Description

CELL-DYN 22 Plus Calibrator is an in-vitro diagnostic product that may contain any or all of the following: stabilized human or mammalian 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. The vials will be packaged in a four (4) welled vacuum formed clamshell container with the package insert / assay sheet. The product must be stored at 2 - 10° C.

AI/ML Overview

Here's an analysis of the provided text regarding the CELL-DYN 22 Plus Calibrator, structured to answer your questions about acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the CELL-DYN 22 Plus Calibrator. Instead, it describes general performance characteristics and equivalence to the predicate device. The "Acceptance Criteria" are implied by the conclusions drawn from the tests, focusing on reproducibility, substantial equivalence, and stability.

Acceptance Criteria (Implied)	Reported Device Performance
Reproducibility	Consistently reproducible
Substantial Equivalence	Substantially equivalent to the predicate product (Cal-Chex)
Open-Vial Stability	Stable for 5 days
Closed-Vial Stability	Stable for 45 days
Fulfillment of Intended Use	Fulfills its intended use when used as instructed in the product information sheet
Safety and Effectiveness	Safe and effective product

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size used for the test set for any of the studies (Run-to-Run Reproducibility, Closed-Vial Stability, Open-Vial Stability, Calibrator Performance Verification, Calibration Equivalency).

The data provenance (country of origin, retrospective/prospective) is not explicitly stated. Given that Streck is a US-based company (Omaha, NE), it is highly probable the studies were conducted in the US. The studies appear to be prospective, laboratory-based verification and validation tests rather than clinical studies with patient data.

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

The document does not mention the involvement of experts for establishing ground truth in the context we typically associate with human interpretation of medical images or diagnostic tests. For a calibrator device, the "ground truth" would be established by reference methods or highly accurate analytical techniques within a laboratory setting, rather than expert consensus on diagnostic interpretations. Therefore, the number and qualifications of experts in this sense are not applicable or reported here.

4. Adjudication Method for the Test Set

As mentioned above, the nature of a calibrator device's validation does not typically involve adjudication methods like "2+1" or "3+1" that are used for subjective interpretations. The "truth" for a calibrator's performance is determined by quantitative measurements against established standards or predicate devices. Therefore, an adjudication method is not applicable or reported here.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and their performance (with or without AI assistance) is evaluated. For a hematology calibrator, this type of study is not appropriate.

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

The device itself is a calibrator, not a diagnostic algorithm. The studies conducted (Run-to-Run Reproducibility, Closed-Vial Stability, Open-Vial Stability, Calibrator Performance Verification, and Calibration Equivalency) are essentially "standalone" performance evaluations of the calibrator's inherent characteristics. The device's "performance" is its ability to consistently provide a known value for calibration, not to make a diagnosis or interpretation. Therefore, in a sense, all listed studies are standalone performance studies of the calibrator material itself.

7. Type of Ground Truth Used

The ground truth for the performance of a calibrator is established by:

Reference materials/standards: For parameters like WBC, RBC, HGB, MCV, PLT, there are established reference methods and materials to determine the true values.
Predicate device comparison: The study explicitly mentions "Calibration Equivalency" to the predicate device, Cal-Chex. This implies the predicate device, with its established performance, serves as a de facto "ground truth" for comparison.
Internal laboratory validation using metrological traceability: Ensuring the calibrator's values are traceable to higher-level reference standards.

The document refers to "Calibrator Performance Verification," which would involve verifying that the calibrator produces expected values when analyzed on the target system (CELL-DYN Emerald 22).

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning algorithms. The CELL-DYN 22 Plus Calibrator is a physical reference material, not an AI or algorithm. Therefore, there is no training set in the conventional sense for this device. Its values are assigned through manufacturing and analytical testing, not an algorithmic learning process.

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

As there is no training set for this calibrator device, this question is not applicable. The values assigned to the calibrator batches are determined through analytical testing and metrological principles, not through an iterative learning process with a "ground truth" dataset.

Summary

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KIII204

510(k) Summary of Safety and Effectiveness

DEC 2 2 2011

, İ

510(k) Submitter:	Streck
	7002 South 109th Street
	Omaha, NE 68128
Official Correspondent:	Bert Moses, Director of Quality
	(402) 537-5343
Date Prepared:	April 12, 2011
Name of Device:
Trade Name:	CELL-DYN 22 Plus Calibrator
Common Name:	Assayed Hematology Calibrator
Classification Name:	Calibrator for Cell Indices (864.8150)
Predicate Device:	Cal-Chex (K840261) Manufactured by Streck

Description:

Intended Use:

CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system.

Assayed parameters include: WBC (109/L), RBC (1012/L), HGB (g/dL), MCV (fL), PLT (108/L)

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Comparison to Predicate Device:

	Cal-Chex (PredicateProduct)	CELL-DYN 22 Plus Calibrator
Intended UseStatement	Cal-Chex is used to calibratemulti-parameter hematologyanalyzer	CELL-DYN 22 Plus Calibrator ismanufactured for calibration of the CELL-DYN Emerald 22 system.Assayed parameters include: WBC(109/L), RBC (1012/L), HGB (g/dL), MCV(fL), PLT (109/L)
Open VialStability	5 days	Same
Closed VialStability	45 days	Same
Reagents	The whole blood reagent maycontain any or all of thefollowing: stabilized humanor mammalian red blood cells,human, mammalian orsimulated white blood cellsand a platelet component in apreservative medium.	Same
StorageConditions	2 - 10°C	Same

Discussion of Tests and Test Results:

Five types of studies were conducted to establish performance of CELL-DYN 22 Plus Calibrator. The five tests conducted were Run-to-Run Reproducibility, Closed-Vial Stability, Open-Vial Stability, Calibrator Performance Venfication and Calibration Equivalency. 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 Calibrator to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. CELL-DYN 22 Plus Calibrator is a safe and effective product, which fulfills its intended use when used as instructed in the product information sheet.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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, a symbol often associated with medicine and healthcare.

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 2 2011

Re: K111204

Trade/Device Name: CELL-DYN 22 Plus Calibrator Regulation Number: 21 CFR 864.8150 Regulation Name: Calibrator for cell indices Regulatory Class: Class II Product Code: KRX 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 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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Indication for Use Form

510(k) Number (if known):

Device Name: CELL-DYN 22 Plus Calibrator

Indications For Use:

CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system.

Assayed parameters include:

WBC (108/L), RBC (1012/L), HGB (g/dL), MCV (fL), PLT (108/L)

Prescription Use × (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)

Mana M. Chen

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

510(k) K111204

Page 1 of 1

Regulation Number and Section

§ 864.8150 Calibrator for cell indices.

(a)
Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). 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.