nRBC-Chex for ADVIA® is an assayed whole blood control designed to evaluate the accuracy and precision of the Siemens Healthcare Diagnostics Inc. hematology analyzers in the measurement of the nucleated red blood cell parameter. Refer to product assay sheet.

Device Description

nRBC-Chex for ADVIA® is stabilized suspension of human and animal blood, 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 two different levels. Level 1 has a low count and Level 2 has a higher count. The vials will be packaged in a two (2) 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 a 510(k) summary for the device "nRBC-Chex for ADVIA®," an assayed hematology control. It details the device's intended use, comparison to a predicate device, and the studies conducted to establish its performance.

Here's an analysis of the acceptance criteria and study information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the "Conclusions Drawn From Tests," and the reported performance is from the "Discussion of Tests and Test Results." Since specific numerical criteria (e.g., "± 5% reproducibility") are not explicitly stated, the acceptance is inferred from the affirmative statements about the device's performance meeting claims.

Acceptance Criteria (Implied)	Reported Device Performance
Closed Vial Stability: Device maintains performance for 45 days.	"nRBC-Chex for ADVIA® meets the claim of a 45 day closed vial stability." and "It meets the claim of a 45 day closed vial... stability."
Open Vial Stability: Device maintains performance for 14 days.	"It meets the claim of ... a 14 day open vial stability."
Run-to-Run Reproducibility: Device is consistently reproducible.	"All testing showed that nRBC-Chex for ADVIA® is consistently reproducible..." and "Reproducibility studies and Closed Vial Stability results confirm lot-to-lot consistency in the manufacture of nRBC-Chex for ADVIA®."
Site-to-Site Recovery of Values: Demonstrates consistent recovery across different sites.	"All testing showed that nRBC-Chex for ADVIA® is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed." (Direct performance for "Site to Site recovery of values" is not explicitly detailed but is covered under the general statement of "All testing showed that nRBC-Chex for ADVIA® is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.")
Substantial Equivalence: Device is substantially equivalent to the predicate.	"All testing showed that nRBC-Chex for ADVIA® is ... substantially equivalent to the predicate product..."
Effectiveness as QC Material: Effective for evaluating accuracy and precision on specified analyzers.	"nRBC-Chex for ADVIA® is an effective quality control material for evaluating the accuracy and precision of the Siemens Healthcare Diagnostics Inc. ADVIA® 2120 in its measurement of the nucleated red blood cell parameter."

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

The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). The studies mentioned (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, Site to Site recovery of values) would typically involve multiple runs and vials, but the specific numbers are not provided.

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

Since this device is an assayed hematology control, "ground truth" is established through measurements by calibrated analytical instruments, rather than human expert opinion. The document does not mention the involvement of human experts for establishing ground truth for the performance studies.

4. Adjudication Method for the Test Set

Not applicable. As a quality control material, the performance is assessed against established measurement principles and instrumental accuracy, not through human adjudication of diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation devices where human readers are involved. This device is a quality control material for automated hematology analyzers, so expert interpretation of cases is not relevant.

6. If a Standalone Study Was Done

Yes, the described studies (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) represent standalone performance evaluations of the nRBC-Chex for ADVIA® device itself, in conjunction with the specified hematology analyzers. The goal was to demonstrate its intrinsic performance as a control material. There is no mention of human-in-the-loop performance being evaluated.

7. The Type of Ground Truth Used

The ground truth for evaluating the performance of "nRBC-Chex for ADVIA®" would be based on instrumental measurements and reference methods. As an assayed hematology control, its values are established by careful measurement on reference analyzers or by comparing to reference materials, ensuring accuracy and precision. The document states it's "designed to evaluate the accuracy and precision" of hematology analyzers, implying its own values are established precisely.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a consumable quality control material, and its development would involve formulation and testing, not a machine learning training phase.

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

Not applicable, as there is no "training set" in the context of device development described here. The ground truth for the assayed values of the control material itself would be established through extensive laboratory testing, calibration, and validation using reference methods and highly accurate analyzers.

Summary

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

K080016

2008

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	FEB - 5
Date Prepared:	January 02, 2008
Name of Device:Trade Name:Common Name:Classification Name:	nRBC-Chex for ADVIA®Assayed Hematology ControlNucleated Cell and Red Blood Cell Control (864.8625)
Predicate Device:	nRBC-Chex for LH (K060083) Manufactured by Streck

Description:

Intended Use:

Comparison to Predicate Device:

nRBC-Chex for LH and nRBC-Chex for ADVIA® are both multi-parameter hematology control materials. They both contain RBC, WBC, and nRBC components. Unlike the 75 day closed vial stability of nRBC-Chex for LH, nRBC-Chex for ADVIA® meets the claim of a 45 day closed vial stability. nRBC-Chex for ADVIA® is designed to evaluate the accuracy and precision of Siemens Healthcare Diagnostics Inc. hematology analyzers listed on the products assay and nRBC-Chex for LH was designed for the Beckman Coulter® LH 750/LH 755.

Discussion of Tests and Test Results:

Four types of studies were conducted to establish performance of nRBC-Chex for ADVIA®. 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 nRBC-Chex for ADVIA® is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.

Conclusions Drawn From Tests:

nRBC-Chex for ADVIA® is an effective quality control material for evaluating the accuracy and precision of the Siemens Healthcare Diagnostics Inc. ADVIA® 2120 in its measurement of the nucleated red blood cell parameter. It meets the claim of a 45 day closed vial, and a 14 day open vial stability and consistent run-to-run performance. Reproducibility studies and Closed Vial Stability results confirm lotto-lot consistency in the manufacture of nRBC-Chex for ADVIA®. Customers can be assured of a reliable quality control material that meets their expectations.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 5 2008

Streck C/O Erin Johnson 7002 South 109th Street Omaha, Nebraska 68128

Re: K080016

Trade/Device Name: NRBC-Chex for Advia Regulation Number: 21 CFR 864.8625 Regulation Name: Assayed Hematology Control Regulatory Class: Class II Product Code: GJR Dated: January 2, 2008 Received: January 3, 2008

Dear Ms. Johnson:

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

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

Page 2 - Streck

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 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 vours,

Robert Baker

Robert L. Becker, Jr., M.D., Ph.D. 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):

nRBC-Chex for ADVIA® Device Name:

Indications For Use:

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)

Josephine Bautista

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Sarety

510(k) K080016

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.