Cell-Chex Auto is an assayed whole blood control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples.

Device Description

Cell-Chex Auto is a stabilized suspension of human red blood cells and simulated white blood cells in a solution containing biological salts and anti-microbial preservatives. The product is packaged in plastic vials containing 4ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels, Level 1 with a very low count, Level with a low count, and a Level 3 with a higher count. 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) summary for the Cell-Chex Auto device. However, it does not contain specific acceptance criteria with numerical targets or a detailed study report that proves the device meets those criteria in the typical format of a clinical trial or performance study comparing against a gold standard with statistical measures.

Instead, the submission focuses on stability and reproducibility studies to demonstrate substantial equivalence to a predicate device.

Here's an attempt to extract the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Specified" due to the nature of this particular 510(k) submission:

Acceptance Criteria and Device Performance

The acceptance criteria are implied to be "consistent reproducibility" and "stability for the shelf life claimed," demonstrating substantial equivalence to the predicate device, iQ® Body Fluids Control (K051706). No specific numerical acceptance criteria (e.g., a target coefficient of variation, accuracy percentage, or confidence intervals) are explicitly stated in the provided text.

Acceptance Criterion (Implied)	Reported Device Performance
Closed Vial Stability: Demonstrated stability for a specified period.	"75 days closed vial stability" (Improved from predicate's 159 days, but still a defined stability period). The study conclusion states it meets "the claim of a 75 day closed vial stability."
Open Vial Stability: Demonstrated stability after opening.	"30 day open vial stability." The study conclusion states it meets "the claim of... a 30 day open vial stability."
Run to Run Reproducibility: Consistent performance across multiple runs.	"consistently reproducible," "consistent run-to-run performance," and "Reproducibility studies... [show] consistency in the manufacture of Cell-Chex Auto." No specific quantitative metrics (e.g., CV%) are provided in this summary.
Site to Site Recovery of Values: Consistent performance across different testing sites.	"All testing showed that Cell-Chex Auto is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed." This implies acceptable recovery of values, but no specific data or metrics are presented.
Substantial Equivalence to Predicate	Implied Performance: "All testing showed that Cell-Chex Auto is... substantially equivalent to the predicate product." The comparison highlights similarities (assayed control, 30-day open vial stability, automated body fluid controls) and a difference (closed vial stability duration). No specific comparison data (e.g., bias, correlation) is provided.

Detailed Study Information:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the provided text. The submission mentions "four types of studies" but does not detail the number of samples or runs performed for each.
- Data Provenance: Not specified (e.g., country of origin). The studies were conducted by the manufacturer, Streck.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is a quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth for a test set. Its performance is evaluated based on its own stability characteristics and reproducibility when run on instruments, likely against a reference assay or manufacturer's target values rather than expert-derived ground truth.
Adjudication Method for the Test Set:
- Not Applicable. (See point 2).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically for evaluating diagnostic imaging or pathology devices where multiple readers interpret cases. Cell-Chex Auto is a quality control material.
- Effect Size: Not applicable.
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance) Study:
- Yes, implicitly. The studies described (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) assess the performance of the control material itself. While hematology instruments are involved, the focus is on the inherent characteristics of the Cell-Chex Auto product rather than a diagnostic algorithm or human interpretation. The "results consistency in the manufacture of Cell-Chex Auto" and its stability are the key performance indicators.
Type of Ground Truth Used:
- Manufacturer's Reference Values / Established Stability Protocols: For a quality control material, the "ground truth" for stability and reproducibility studies typically refers to the manufacturer's established target values or range for the control material, and the adherence to pre-defined stability protocols (e.g., measuring values over time at specified conditions and comparing them to initial values or expected ranges). It is not pathology, expert consensus, or outcomes data in this context.
Sample Size for the Training Set:
- Not Applicable. This device is a quality control material, not an AI/ML algorithm that requires a "training set." Its development involves formulation, manufacturing process control, and performance testing, not algorithmic training.
How the Ground Truth for the Training Set was Established:
- Not Applicable. (See point 7).

Summary

{0}------------------------------------------------

K053362

510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128
Official Correspondent:	Carol Thompson, Quality Assurance Manager(402)-537-5213
Date Prepared:	December 1, 2005
Name of Device:Trade Name:Common Name:Classification Name:	Cell-Chex AutoHematology Control for Body FluidsWhite and Red Blood Cell Control (864.8625)
Predicate Device:	iQ® Body Fluids Control (K051706) Manufactured by Streck

Description:

Intended Use:

Cell-Chex Auto is an assayed whole blood control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples.

Comparison to Predicate Device:

Like iQ Body Fluids Control, Cell-Chex Auto is an assayed control mixture of red and white blood cells set at specific concentrations. iQ Body Fluids Control and Cell-Chex Auto have a 30 day open vial stability. Both iQ Body Fluids Control and Cell-Chex Auto are automated body fluid controls.

Unlike iQ Body Fluids Control, Cell-Chex Auto has 75 days closed vial stability where iQ Body Fluids Control has 159 days closed vial stability

Discussion of Tests and Test Results:

Four types of studies were conducted to establish performance of Cell-Chex Auto. The four tests conducted were Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values. All testing showed that Cell-Chex Auto is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.

Conclusions Drawn From Tests:

Cell-Chex Auto is an effective quality control material for controlling hematology instruments that measure blood cell counts in body fluid samples when used as indicated on the labeling. It meets the claim of a 75 day closed vial, and a 30 day open vial stablity and consistent run-to-run performance, Reproducibility studies and Closed Vial stability results consistency in the manufacture of Cell-Chex Auto. Customers can be assured of a reliable quality control material that meets their expectations.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human figures, each represented by a curved line, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JAN 1 3 2006

Re: K053362 Trade/Device Name: Cell-Chex Auto Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: December 1, 2005 Received: December 2, 2005

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.

{2}------------------------------------------------

Page 2 -

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 (240) 276-0484. 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/industry/support/index.html

Sincerely yours,

Robert Beckerh

Robert L. Becker, Jr., MD, Ph Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known):

K053362

Device Name:

Cell-Chex Auto

Indications For Use:

Cell-Chex Auto is an assayed whole blood control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples.

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

Office of In Wire Diagnostic Device Evaluation and Satury

Page 1 of 1

510(2) K053362

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.