Cell-Chex 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 monosodium urate crystals which can be used to monitor the presence of crystals in synovial fluid.

Cell-Chex 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 is a stabilized suspension of human red blood cells, human white blood cells and monosodium urate 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 polyethylene liners. There are two different levels. Level 1 contains a low cell count and monosodium urate 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 "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.

AI/ML Overview

The provided text describes the 510(k) submission for "Cell-Chex," a hematology control for body fluids. The device is intended for monitoring total cell counts and white blood cell differentiation using manual methods (hemocytometer and Cytospin® smears). The key change from the predicate device is the addition of monosodium urate crystals in Level 1 for monitoring crystal presence in synovial fluid.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for various performance metrics. Instead, it describes the types of studies conducted and their general conclusions. The "reported device performance" is qualitative, indicating the device meets its intended use and is comparable to the predicate.

Acceptance Criterion (Implicit from Study Types)	Reported Device Performance
Closed Vial Stability	Cell-Chex is stable for the shelf life claimed (60 days).
Open Vial Stability	Cell-Chex is stable for the open vial stability claimed (30 days).
Run-to-Run Reproducibility	Cell-Chex is consistently reproducible.
Precision Performance Data	Cell-Chex performs comparably to the predicate product.
Crystal Detection (Level 1 only)	Can be used to monitor the presence of crystals in synovial fluid (listed as positive or negative).

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

The document does not specify the sample size for the test sets used in the Closed Vial Stability, Open Vial Stability, Run-to-Run Reproducibility, or Precision Performance Data studies.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. Given the nature of a control device, the "data" would likely originate from internal testing conducted by the manufacturer (Streck).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for a test set in the traditional sense of clinical readings. This device is a control product, meaning its performance is evaluated against expected values for cell counts and crystal presence, not against expert interpretations of patient samples.

4. Adjudication Method for the Test Set

Since there were no human readers or expert interpretations of a test set of patient cases, an adjudication method like 2+1 or 3+1 is not applicable and therefore, not mentioned.

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

No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically conducted for diagnostic devices where human interpretation directly impacts diagnosis and patient outcomes, and the AI is meant to assist human readers. Cell-Chex is a control used to validate the manual counting procedures, not a diagnostic AI system itself.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was done. Cell-Chex is a physical control material and does not involve an algorithm with standalone performance. Its purpose is to provide known values for manual counting methods.

7. Type of Ground Truth Used

The "ground truth" for Cell-Chex's performance is established by its known, pre-defined characteristics as a control material. This includes:

Expected cell counts (red blood cells, white blood cells).
Expected white blood cell differentiation percentages.
Presence or absence of monosodium urate crystals (for Level 1).

These values are determined during the manufacturing and characterization of the control product itself, rather than by expert consensus on external patient data or pathology. The studies (stability, reproducibility, precision) then verify that the product consistently maintains these known characteristics over time and across different manufacturing lots.

8. Sample Size for the Training Set

There is no mention of a training set sample size. This device does not involve a machine learning algorithm that requires training data.

9. How Ground Truth for the Training Set was Established

As there is no training set for a machine learning algorithm, this question is not applicable. The "ground truth" for the control material's inherent properties is established through the manufacturing process and quality control measures.

Summary

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K101335

510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128
Official Correspondent:	Kerrie Oetter, Regulatory Affairs Specialist(402)-537-5215
Date Prepared:	August 5, 2010
Name of Device:
Trade Name:	Cell-Chex™
Common Name:	Hematology Control for Body Fluids
Classification Name:	White and Red Blood Cell Control (864.8625)
Predicate Device:	Cell-Chex™ (K000076) Manufactured by Streck

AUG 2 3 2010#### Description:

Intended Use:

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Comparison to Predicate Device:

	Cell-Chex - original (PredicateProduct)	Cell-Chex - New with crystal
Intended UseStatement	Cell-Chex is an assayed controlintended for monitoring total cellcounts performed manually using ahemocytometer to validatequantitation of red and whiteblood cells in patientcerebrospinal fluid and bodysamples including pleural,pericardial, peritoneal andsynovial fluid. It is also intendedfor monitoring white blood celldifferentiation in body fluidsamples performed usingCytospin smears.	Cell-Chex is an assayed controlintended for monitoring total cellcounts performed manually using ahemocytometer to validatequantitation of red and white bloodcells in patient cerebrospinal fluidand body fluid samples includingpleural, pericardial, peritoneal andsynovial fluid. Level 1 containsmonosodium urate crystals whichcan be used to monitor thepresence of crystals in synovialfluid.Cell-Chex is also intended formonitoring white blood celldifferentiation (Mononuclear,Ploymorphonuclear; Neutrophils,Eosinophils, Basophils,Lymphocytes and Monocytes) inbody fluid samples performed usingCytospin® smears.
Open VialStability	30 days	Same
Closed VialStability	6 months	60 days
Reagents	Stabilized human red blood cellsand human white blood cells in apreservative medium.	Stabilized human red blood cells,human white blood cells andmonosodium urate crystals (Level 1only) in a preservative medium.
StorageConditions	2 - 10°C	Same
The only difference relative to the predicate product (i.e. Cell-Chex), which has been on

the market since 2000 is the addition of the crystal component. The product composition and the associated product usage applications (i.e. hemacytometer and Cytospin™ smears) are unchanged. The crystal component is intended to be listed on the assay as positive or negative (i.e. present or not present).

Discussion of Tests and Test Results:

Four types of studies were conducted to establish performance of Cell-Chex. The four tests conducted were Closed Vial Stability, Open Vial Stability, Run-to-Run Reproducibility, and Precision Performance Data. All testing showed that Cell-Chex 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 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 comparably to the predicate product. It is safe and effective product when used as indicated in 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 eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Streck c/o Ms. Kerrie Oetter Regulatory Affairs Specialist 7002 South 109th Street Omaha, NE 68128

AUG 2 3 2010

Re: K101335

Trade/Device Name: Cell-Chex™ Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GLO Dated: July 26, 2010 Received: July 27, 2010

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 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

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Page 2 - Ms. Kerrie Oetter

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.

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,

ia 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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K101335

Indication for Use Form

510(k) Number (if known): K101335

Device Name: Cell-Chex™ AUG 2 3 2010

Indications For Use:

Cell-Chex 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, peritoneal and synovial fluid. Level 1 contains monosodium urate crystals which can be used to monitor the presence of crystals in synovial fluid.

Cell-Chex 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

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)

Maria M. Chan

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

510(k) K101335

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.