(51 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the iQ® Body Fluids Control device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly state numerical acceptance criteria (e.g., minimum accuracy percentages, specific standard deviations). Instead, it describes general performance categories and concludes qualitative success.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Closed Vial Stability | "All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim." |
| Open Vial Stability | "All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim." (Note: The text specifically mentions "closed vial stability claim" after discussing open vial stability, implying open vial stability was also met, but the wording is slightly ambiguous.) |
| Alternate Site Testing | "All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim." (Same note as above.) |
| Run-to-Run Reproducibility | "All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim." (Same note as above.) |
| Overall Safety and Effectiveness | "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." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the sample size used for the test sets in any of the studies (closed vial stability, open vial stability, alternate site testing, or run-to-run reproducibility).
The data provenance is internal to Streck as the manufacturer. There is no information about the country of origin of the data or whether the studies were retrospective or prospective. Given these are stability and reproducibility studies for a control material, they would inherently be prospective in nature, conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in the context of this device. The iQ® Body Fluids Control is a quality control material, not a diagnostic device that interprets medical images or patient data requiring expert consensus or ground truth establishment in the traditional sense. The "ground truth" for a control material would be its manufacturing specifications and target values, verified through laboratory assays.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3. There is no expert adjudication involved in determining the performance of a hematology control material. Its performance is assessed against established laboratory standards and its own pre-defined target values and acceptable ranges.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in interpreting clinical cases (e.g., radiologists reading medical images). The iQ® Body Fluids Control is a quality control material for an analyzer, not a device used by human readers for diagnostic interpretation.
Effect Size: N/A, as no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not directly applicable in the common sense of algorithm-only performance for a diagnostic device. However, the studies conducted (closed vial stability, open vial stability, alternate site testing, and run-to-run reproducibility) represent "standalone" performance of the control material itself when run on the iQ® Series analyzers. The device (the control material) is used independently by the analyzer to verify its performance specifications. There is no "human-in-the-loop" component for the control material's own performance evaluation; its function is to assess the analyzer's performance.
7. The Type of Ground Truth Used:
The "ground truth" for the iQ® Body Fluids Control would be its reference values and acceptable ranges established through rigorous assaying and manufacturing processes. These values are determined by:
- Manufacturer-defined specifications: The expected concentration of red blood cells and simulated white blood cells based on the formulation.
- Laboratory assay methods: The control material is tested using validated laboratory methods on suitable reference instruments to establish its target values and expected variability.
- Statistical analysis: To define the acceptable ranges for the control material's performance over its claimed stability period.
It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
This information is not applicable as the iQ® Body Fluids Control is a chemical reagent/biological control material, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of device.
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AUG 1 7 2005
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 |
| 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.
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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
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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
§ 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.