(42 days)
Not Found
No
The device is a hematology control material, not a diagnostic instrument or software that would typically incorporate AI/ML for analysis. The description focuses on the composition and stability of the control material.
No
This device is an assayed whole blood control used to evaluate the accuracy and precision of hematology instruments, not to treat a patient.
No.
Cell-Chex Auto is a control material used to evaluate the accuracy and precision of hematology instruments, not a device that directly diagnoses patient conditions.
No
The device description clearly indicates it is a physical product (stabilized suspension of human red blood cells and simulated white blood cells) packaged in vials, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it 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." This clearly indicates its use in a laboratory setting to assess the performance of diagnostic instruments.
- Device Description: The description details a "stabilized suspension of human red blood cells and simulated white blood cells" used for testing hematology instruments. This is a typical description of an in vitro diagnostic control material.
- Performance Studies: The document describes performance studies conducted to establish the stability and reproducibility of the product, which are standard requirements for IVD devices.
- Predicate Device: The mention of a predicate device (K051706; iQ® Body Fluids Control) which is also an IVD control further supports that this device falls under the IVD category.
Therefore, based on the provided information, Cell-Chex Auto is an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JPK
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.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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: | December 1, 2005 |
| Name of Device:
Trade Name:
Common Name:
Classification Name: | Cell-Chex Auto
Hematology Control for Body Fluids
White and Red Blood Cell Control (864.8625) |
| Predicate Device: | iQ® Body Fluids Control (K051706) Manufactured by Streck |
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.
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.
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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.
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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,
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
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510(k) Number (if known):
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
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510(2) K053362