CD4 Count is a suspension of stabilized human blood packaged in a plastic vial OD4 Obant 16 a cuppinelon the vials are packaged in a vacuum formed "clam-shell" box.

AI/ML Overview

The provided text describes a 510(k) summary for the device "CD4 Count," an immunophenotyping control. The studies conducted primarily revolve around the device's stability, reproducibility, and substantial equivalence to a predicate device, rather than a clinical performance study involving human subjects or expert readers for diagnostic accuracy. Therefore, many of the requested categories are not applicable to this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a typical "performance metric" vs. "threshold" format. Instead, it concludes that the device is "consistently reproducible and stable for the entire product dating" and "substantially equivalent to the predicate product." The comparison table with the predicate device implies the stability periods as key attributes demonstrating equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Reproducibility	"consistently reproducible"
Stability for entire product dating (Closed Vial)	"stable for the entire product dating" (specifically, 60 days)
Stability for entire product dating (Open Vial)	"stable for the entire product dating" (specifically, 30 days)
Substantial Equivalence to Predicate (CD-Chex® Plus BC)	"substantially equivalent to the predicate product"
Intended Use Fulfillment	"fulfills its intended use when used as instructed in the product package insert"
Open Vial Stability (compared to predicate, 30 days)	Same (30 days)
Closed Vial Stability (compared to predicate, 90 days)	60 days (Note: This is shorter than the predicate, but deemed acceptable for product dating)
Reagents	Same (stabilized human blood in preservative medium)
Storage Conditions	Same (2 - 10°C)

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

The document mentions "Four studies of CD4 Count were conducted" but does not specify the sample sizes (e.g., number of vials, number of runs, number of samples per run) for any of these studies. It also does not explicitly state the country of origin for the data or whether it was retrospective or prospective, though general product development/validation studies are typically prospective.

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

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. The "ground truth" for a control would relate to its manufacturing specifications and stability.

4. Adjudication Method for the Test Set:

Not applicable. There was no diagnostic test set requiring human adjudication.

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 quality control material and does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical control material and does not involve an algorithm for diagnostic performance.

7. The Type of Ground Truth Used:

The ground truth implicitly used for this type of quality control device would be:

Manufacturing Specifications: The inherent properties and expected values established during the manufacturing process for the control material.
Reference Method/Predicate Device Comparison: Performance relative to a legally marketed predicate device (CD-Chex® Plus BC) and established flow cytometry methods for assessing reproducibility and stability.

8. The Sample Size for the Training Set:

Not applicable. This device is a quality control material, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There was no training set for a machine learning model.

Summary

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K083926

510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128
Official Correspondent:	Carol Thompson, Quality Assurance Manager(402) 537-5313
Date Prepared:	December 30, 2008
Names of Device:
Trade Name:	CD4 Count
Common Name:	Immunophenotyping Control
Classification Name:	White Cell Control, 21CFR864.8625
Predicate Device:	CD-Chex® Plus BC (K051633)

Predicate Device:

Description: CD4 Count is a suspension of stabilized human blood packaged in a plastic vial OD4 Obant 16 a cuppinelon the vials are packaged in a vacuum formed "clam-shell"

Intended Use: ·

box.

CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument

Comparison with Predicate Device:

	CD-Chex Plus BC(Predicate Product)	CD4 Count
Intended Use Statement	CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments.	CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument
Open Vial Stability	30 days	Same
Closed Vial Stability	90 days	60 days
Reagents	Contains stabilized human blood in a preservative medium.	Same
Storage Conditions	2 - 10°C	Same

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Testing Performed:

Four studies of CD4 Count were conducted: 1) Run to Run Reproducibility & Whole Pour Statios of OD F Stability, 3) Closed Vial Stability, and 4) Alternate Site Testing. Study results showed CD4 Count to be consistently reproducible and stable for the entire product dating.

Conclusions Drawn from the Tests:

Study results show CD4 Count to be consistently reproducible, substantially equivalent i to the predicate product, and stable for the entire product dating. CD4 Count is a safe lo the product, which fulfills its intended use when used as instructed in the product package insert.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Streck Inc. c/o Ms. Kerrie Oetter Ouality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128

FEB 1 1 2009

Re: K083926

Trade/Device Name: CD4 Count Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: GGL Dated: December 30, 2008 Received: December 31, 2008

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 (OS) 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.

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Page 2 - Ms. Kerrie Oetter

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Maria Inchar

Maria M. Chan, Ph.D. Acting Division 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

K083926 510(k) Number (if known):

Device Name: CD4 Count

Indication For Use:

CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Joachim Bautista

Division Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K083926

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.