(33 days)
Not Found
No
The device description and performance studies focus on the stability and reproducibility of a blood control material, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as an assayed whole blood control used to evaluate the accuracy and precision of hematology analyzers, indicating it's a diagnostic control, not a therapeutic device.
No.
The document states that this device is a control designed to evaluate the accuracy and precision of hematology analyzers, not to diagnose a patient's condition.
No
The device description clearly states it is a "stabilized suspension of human and animal blood" packaged in vials, indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is "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." This indicates it is used in vitro (outside the body) to assess the performance of a diagnostic instrument.
- Device Description: It is a "stabilized suspension of human and animal blood" and is used as a "whole blood control." Controls are a fundamental component of IVD testing to ensure the reliability of the analytical process.
- Performance Studies: The performance studies described (Stability, Reproducibility, Site to Site recovery) are typical evaluations for IVD control materials to demonstrate their suitability for their intended purpose.
- Predicate Device: The predicate device listed (K060083; nRBC-Chex for LH) is also a control material for hematology analyzers, further supporting its classification as an IVD.
Based on the intended use, device description, and the context of its use with hematology analyzers, nRBC-Chex for ADVIA® clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"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."
Product codes
GJR
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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
2008
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck
7002 South 109th Street
Omaha, 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 Control
Nucleated Cell and Red Blood Cell Control (864.8625) | |
| Predicate Device: | nRBC-Chex for LH (K060083) Manufactured by Streck | |
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.
Intended Use:
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.
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
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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 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:
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.
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
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