(51 days)
Not Found
No
The device description and performance studies focus on the stability and reproducibility of a control solution for cell counting, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is a control for evaluating body fluid cell counts on an analyzer, not for treating a condition.
No
This device is a control for evaluating cell counts on other analyzers, not a diagnostic device itself.
No
The device description clearly states it is a "stabilized suspension of human red blood cells and simulated white blood cells in a solution containing biological salts and anti-microbial preservatives," packaged in glass vials. This describes a physical, tangible product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "evaluating body fluid RBC and nucleated cell counts" on specific analyzers. This is a diagnostic purpose, providing information about a patient's body fluids.
- Device Description: The description details a "stabilized suspension of human red blood cells and simulated white blood cells" used as a control. Controls are essential components in in vitro diagnostic testing to ensure the accuracy and reliability of the results.
- Predicate Device: The mention of a predicate device (K000076 Cell-Chex) which is also a control for hematology analyzers, further supports its classification as an IVD. Predicate devices are used to demonstrate substantial equivalence for regulatory purposes, and they are typically other IVDs.
Therefore, based on the intended use, device description, and the reference to a predicate device, the iQ® Body Fluids Controls clearly fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
iQ® Body Fluids Controls are intended for use on iQ® Series analyzers, with the optional iQ® Body Fluids Module installed, as a control for evaluating body fluid RBC and nucleated cell counts. The device will consist of two levels of red blood cells and nucleated cells.
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
iQ Body Fluids Control 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 glass vials containing 8ml. The closures are polypropylene screw caps with polyethylene liners. Four vials are included in a set. Two vials are level 1 with a low cell count and the other two vials are level 2 with a higher concentration of cells. The vials are further packaged in a six (6) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 – 10°C.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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 iQ Body Fluids Control, closed vial stability, open vial stability, alternate site testing, and run to run reproducibility. All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim.
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.
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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
AUG 1 7 2005
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: | June 14, 2005 |
| Name of Device: | |
| Trade Name: | iQ® Body Fluids Control |
| Common Name: | Hematology Control for Body Fluids |
| Classification Name: | White and Red Blood Cell Control (864.8625) |
| Predicate Device: | Cell-Chex (K000076) Manufactured by Streck |
Description:
iQ Body Fluids Control 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 glass vials containing 8ml. The closures are polypropylene screw caps with polyethylene liners. Four vials are included in a set. Two vials are level 1 with a low cell count and the other two vials are level 2 with a higher concentration of cells. The vials are further packaged in a six (6) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 – 10°C.
Intended Use:
iQ® Body Fluids Controls are intended for use on iQ® Series analyzers, with the optional iQ® Body Fluids Module installed, as a control for evaluating body fluid RBC and nucleated cell counts. The device will consist of two levels of red blood cells and nucleated cells.
Comparison to Predicate Device:
Like Cell-Chex, iQ Body Fluids Control is an assayed control mixture of red and white blood cells set at specific concentrations. Cell-Chex and iQ Body Fluids Control have a 30 day open vial stability.
Unlike Cell-Chex, iQ Body Fluids Control is used for the Iris Diagnostics' iQ Body Fluids Module. Cell-Chex is used with manual diagnostic methods, and Cell-Chex has a 6 (six) month closed vial stability where iQ Body Fluids Control has a 40 day closed vial stability.
Discussion of Tests and Test Results:
Four types of studies were conducted to establish performance of iQ Body Fluids Control, closed vial stability, open vial stability, alternate site testing, and run to run reproducibility. All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim.
Conclusions Drawn From Tests:
iQ Body Fluids Control is a safe and effective product useful for controlling the Iris Diagnositc Body Fluid Module. It will perform as claimed when used in accordance with the package insert.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 7 2005
Mr. Mark Lewallen Quality Assurance Coordinator Streck 7002 South 109th Street La Vista, Nebraska 68128
K051706 Re:
Trade/Device Name: iQ® Body Fluids Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: August 10, 2005 Received: August 11, 2005
Dear Mr. Lewallen:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave a nowe 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 for assession 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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Page 2 -
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 or questions on the promie Evaluation and Safety at (240) 276-0484. Also, please note the vitro Diagnostic D' Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain other generers, 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, PAD 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):
Device Name:
Indications For Use:
Kosi706
iQ® Body Fluids Control
iQ® Body Fluids Controls are intended for use on iQ® Series analyzers, with the optional iQ® Body Fluids Module installed, as a control for evaluating body fluid RBC and nucleated cell counts. The device will consist of two levels of red blood cells and nucleated cells.
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 Buatta
Division
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k) K051706