Cell-Chex™ with CPPD Crystals is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dihydrate (CPPD) Crystals which can be used to monitor the presence of crystals in synovial fluid.

Cell-Chex™ with CPPD Crystals is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears.

Device Description

Cell-Chex™ with CPPD Crystals is a stabilized suspension of human red blood cells, human white blood cells and calcium pyrophosphate dihydrate (CPPD) Crystals (Level 1 only) in a preservative medium. The product is packaged in glass vials containing 2.0ml. The closures are polypropylene screw caps with polvethylene liners. There are two different levels. Level 1 contains a low cell count and CPPD crystals, and Level 2 contains a high cell count and no crystals. The vials will be packaged in a six (6) or twelve (12) welled vacuum formed clamshell container with the package insert / assay sheet. The product must be stored at 2 - 10°C.

AI/ML Overview

The provided text describes the Cell-Chex™ with CPPD Crystals device, its intended use, and a comparison to a predicate device (Cell-Chex™). It also mentions the types of studies conducted to establish its performance. However, it does not explicitly state "acceptance criteria" in a quantitative format or report specific numerical performance metrics against those criteria. Instead, the studies aim to demonstrate reproducibility, substantial equivalence to the predicate, and stability.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria. Instead, it frames the success of the studies in terms of "consistently reproducible," "substantially equivalent to the predicate product," and "stable for the shelf life claimed."

Acceptance Criteria (Implied)	Reported Device Performance
Device is consistently reproducible.	"All testing showed that Cell-Chex™ with CPPD crystals is consistently reproducible..."
Device is substantially equivalent to the predicate product.	"All testing showed that Cell-Chex™ with CPPD crystals is ... substantially equivalent to the predicate product..." and "Results presented show it is consistently reproducible and performs compably to the predicate product." The only difference is the type of crystal (CPPD vs. monosodium urate).
Device is stable for the claimed shelf life (open and closed).	"All testing showed that Cell-Chex™ with CPPD crystals is ... stable for the shelf life claimed."
Device fulfills its intended use.	"Cell-Chex™ with CPPD Crystals fulfills its intended use as a control mixture for manual counting of Red Blood Cells and White Blood Cells in body fluids..."
Device is safe and effective.	"Cell-Chex™ with CPPD Crystals is a safe and effective product when used as indicated in the instructions for use."

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

The document does not explicitly state the sample sizes used for the "Closed Vial Stability," "Open Vial Stability," "Run-to-Run Reproducibility," and "Precision Performance" studies. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not describe the use of experts or the establishment of ground truth in the context of clinical or diagnostic performance for the test set. The device is a "Hematology Quality Control Mixture," meaning its "ground truth" (i.e., its expected cell counts and crystal presence) is internally derived from its manufacturing specifications and assessed through analytical studies, rather than by expert interpretation of patient samples.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for this control device is based on its composition and manufacturing specifications, not on expert adjudication of diagnostic images or clinical cases.

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 hematology quality control mixture, not an AI or imaging device requiring human reader interpretation or assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a laboratory control, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device is its manufactured composition and stability characteristics. For example, Level 1 contains CPPD crystals, and its expected cell counts (low count) are inherent to its design as a control. The studies focused on confirming that these inherent properties are maintained over time (stability) and are consistently met across manufacturing runs (reproducibility and precision).

8. The Sample Size for the Training Set

Not applicable. This is a physical control product, not an AI/machine learning model that requires a training set. The studies described are analytical validation studies.

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

Not applicable, as there is no training set for an AI/machine learning model. The "ground truth" for the control material itself is established through its formulation, manufacturing process, and characterization by the manufacturer.

Summary

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K110718

MAY 2 6 2011

510/k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128
Official Correspondent:	Deborah Kipp, Quality Assurance Coordinator(402) 537-5215
Date Prepared:	March 14, 2011
Name of Device:Trade Name:Common Name:Classification Name:	Cell-Chex™ with CPPD CrystalsHematology Control for Body FluidsHematology Quality Control Mixture (864.8625)
Predicate Device:	Cell-Chex™ (K101335) Manufactured by Streck

Description:

Intended Use:

Cell-Chex™ with CPPD Crystals is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dihydrate (CPPD) Crvstals which can be used to monitor the presence of crystals in synovial fluid.

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Comparison to Predicate Device:

	Cell-Chex™ (Predicate Product)	Cell-Chex™ with CPPD Crystals
Intended UseStatement	Cell-Chex™ is an assayed control intendedfor monitoring total cell counts performedmanually using a hemocytometer to validatequantitation of red and white blood cells inpatient cerebrospinal fluid and body fluidsamples including pleural, pericardial,peritoneal and synovial fluid. Level 1contains monosodium urate crystals which	Cell-Chex™ with CPPD Crystals is anassayed control intended for monitoring totalcell counts performed manually using ahemocytometer to validate quantitation of redand white blood cells in patient cerebrospinalfluid and body fluid samples including pleural,pericardial, peritoneal and synovial fluid.Level 1 contains calcium pyrophosphate
	can be used to monitor the presence ofcrystals in synovial fluid.Cell-Chex™ is also intended for monitoringwhite blood cell differentiation (Mononuclear,Polymorphonuclear; Neutrophils,Eosinophils, Basophils, Lymphocytes andMonocytes) in body fluid samples performedusing Cytospin® smears.	dihydrate (CPPD) crystals, which can beused to monitor the presence of crystals insynovial fluid.Cell-Chex™ with CPPD Crystals is alsointended for monitoring white blood celldifferentiation (Mononuclear,Polymorphonuclear; Neutrophils,Eosinophils, Basophils, Lymphocytes andMonocytes) in body fluid samples performed
Open VialStability	30 days	using Cytospin® smears.Same
Closed VialStability	60 days	Same
Reagents	Stabilized human red blood cells, humanwhite blood cells and monosodium uratecrystals (Level 1 only) in a preservativemedium.	Stabilized human red blood cells, humanwhite blood cells CPPD crystals (Level 1only) in a preservative medium.
StorageConditions	2 - 10°C	Same
The only difference relative to the predicate product (i.e. Cell-Chex™) is the substitution of theinert CPPD crystal component for the inert urate crystals in the Level 1 control. Level 2contains the same formulation as Cell-Chex™ (K101335). The product composition and theassociated product usage applications (i.e. hemocytometer and Cytospin® smears) areunchanged. The CPPD crystal component is intended to be listed on the assay as positive or

Discussion of Tests and Test Results:

negative (i.e. present or not present).

Four types of studies were conducted to establish performance of Cell-Chex with CPPD Crystals. The four tests conducted were Closed Vial Stability, Open Vial Stability, Runto-Run Reproducibility, and Precision Performance. All testing showed that Cell-Chex™ with CPPD crystals is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.

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Conclusions Drawn From Tests

Cell-Chex™ with CPPD Crystals fulfills its intended use as a control mixture for manual counting of Red Blood Cells and White Blood Cells in body fluids such as cerebrospinal fluid. Results presented show it is consistently reproducible and performs compably to the predicate product. Cell-Chex™ with CPPD Crystals is a safe and effective product when used as indicated in the instructions for use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure 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.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

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

Re: K110718

Trade/Device Name: Cell-Chex™ with CPPD Crystals Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GLQ Dated: March 14, 2011 Received: March 15, 2011

MAY 2 6 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 will allow you to begin marketing your device as described in your Section 510(k) premarket

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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 Chen

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 Form

510(k) Number (if known): K | | 07718

Device Name:

Cell-Chex™ with CPPD Crystals

Indications For Use:

Cell-Chex™ with CPPD Crystals is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including plural, pericardial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dihydrate (CPPD) Crystals, which can be used to monitor the presence of crystals in svnovial fluid.

Cell-Chex™ with CPPD Crystals is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears

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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110718

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.