(29 days)
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No
The summary describes a blood control product used to evaluate the performance of a hematology analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies. The device is a physical control material, not a software or algorithm-based system.
No
The device is a control material used to evaluate the accuracy and precision of an analytical instrument (Beckman Coulter LH 750) in measuring nucleated red blood cells, not to treat a patient.
No
The device is described as an "assayed whole blood control designed to evaluate the accuracy and precision of the Beckman Coulter® LH 750 in its measurement of the nucleated red blood cell parameter." This indicates it's a quality control device for another diagnostic instrument, not a diagnostic device itself.
No
The device description clearly states it is a stabilized suspension of human and animal blood, packaged in vials, indicating it is a physical substance and not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "an assayed whole blood control designed to evaluate the accuracy and precision of the Beckman Coulter® LH 750 in its measurement of the nucleated red blood cell parameter." This clearly indicates that the device is used in vitro (outside the body) to assess the performance of a diagnostic instrument.
- Device Description: The description mentions it's a "stabilized suspension of human and animal blood" and is used as a "control." Controls are a fundamental component of IVD testing to ensure the reliability of the diagnostic process.
- Performance Studies: The description of performance studies (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) are typical studies conducted to validate the performance of an IVD control.
- Predicate Device: The mention of a predicate device (K000945 Para 12 Plus Retics) is common for IVD submissions to demonstrate substantial equivalence to a previously cleared device.
Therefore, all the key indicators point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
nRBC-Chex for LH is an assayed whole blood control designed to evaluate the accuracy and precision of the Beckman Coulter® LH 750 in its measurement of the nucleated red blood cell parameter.
Product codes
GJR, GGL
Device Description
nRBC-Chex for LH 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 six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package in a sk (v) product must be stored at 2 - 10°C.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Four types of studies were conducted to establish performance of nRBC-Chex for LH. The four tests conducted were Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All testing showed that nRBC-Chex for LH is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf ife clained. nRBC-Chex for LH is an effective quality control material for evaluating the accuracy and precision of the Beckman Coulter LH 750 in its measurement of the rucleated red blood cell parameter. It meets the claim of a 75 day closed vial, and a 14 day open vial stability and consistent run-to-run performance. Reproducibility studies and Closed Vial Stability results confirm lot-to-lot consistency in the manufacture of nRBC-Chex for LH.
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
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 |
| Date Prepared: | January 10, 2006 |
| Name of Device: | |
| Trade Name: | nRBC-Chex for LH |
| Common Name: | Assayed Hematology Control |
| Classification Name: | Nucleated Cell and Red Blood Cell Control (864.8625) |
| Predicate Device: | Para 12 Plus Retics (K000945) Manufactured by Streck |
Description:
nRBC-Chex for LH 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 six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package in a sk (v) product must be stored at 2 - 10°C.
Intended Use:
nRBC-Chex for LH is an assayed whole blood control designed to evaluate the accuracy and precision of Beckman Coulter® LH 750 in its measurement of the nucleated red blood cell parameter.
Comparison to Predicate Device:
Para 12 Plus Retics and nRBC-Chex for LH are both multi-parameter hematology control materials. They both contain RBC, WBC, and NRBC components. Unlike Para 12 Plus Retics, nRBC-Chex for LH does not include reticulosyte or platelet components. The suspending diluents are similar. Both Para 12 Plus Retics and nRBC-Chex for LH have closed vial stability performance claims of 7 days.
Discussion of Tests and Test Results:
Four types of studies were conducted to establish performance of nRBC-Chex for LH. 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 LH is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf ife clained.
Conclusions Drawn From Tests:
nRBC-Chex for LH is an effective quality control material for evaluating the accuracy and precision of the Beckman Coulter LH 750 in its measurement of the rucleated red blood cell parameter. It meets the claim of a 75 day closed vial, and a 14 day open vial stability and consistent run-to-run performance. Reproducibility studies and Closed Vial Stability results confirm lot-to-lot consistency in the manufacture of nRBC-Chex for LH. Customers can be assured of a reliable quality control material that meets their expectations.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.
Public Health Service
Ms. Kerrie Oetter Quality Assurance Coordinator Streck Laboratories, Inc. 7002 South 109th Street La Vista, NE 68128
Re: K060083
Trade/Device Name: nRBC-Chex for LH Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GJR, GGL Dated: January 10, 2006 Received: January 11, 2006
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); 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.
2006 FEB 9
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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,
lobatz Beckerh
Robert L. Becker, Jr., MD, PK 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):
K0600083
Device Name:
nRBC-Chex for LH
Indications For Use:
nRBC-Chex for LH is an assayed whole blood control designed to evaluate the accuracy and precision of the Beckman Coulter® LH 750 in its measurement of the nucleated red blood cell parameter.
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-
Page_1_of _1
Office of In Vitro Diagnostic Device Evaluation and Safety
310(k) K060083