(237 days)
Not Found
No
The device is a calibrator for a hematology analyzer, consisting of stabilized blood components in a preservative medium. The description focuses on the physical composition, packaging, and storage, with no mention of software, algorithms, or AI/ML capabilities. The performance studies described are standard tests for calibrator stability and reproducibility, not related to AI/ML model performance.
No
This device is an in-vitro diagnostic product used for calibrating laboratory equipment (CELL-DYN Emerald 22 system), not for treating a disease or condition in a patient.
No
Explanation: The device is described as a "Calibrator" and "in-vitro diagnostic product" used for the "calibration of the CELL-DYN Emerald 22 system," not for diagnosing a condition or disease in a patient. It is used to ensure another diagnostic device is working correctly.
No
The device description clearly states it is an in-vitro diagnostic product containing biological components (stabilized human or mammalian red blood cells, white blood cells, platelet component) in a preservative medium, packaged in physical vials. This indicates a physical reagent product, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "manufactured for calibration of the CELL-DYN Emerald 22 system." Calibration is a crucial step in ensuring the accuracy of an in vitro diagnostic device (the CELL-DYN Emerald 22 system), which analyzes biological samples (blood) to provide diagnostic information.
- Device Description: The device description clearly states "CELL-DYN 22 Plus Calibrator is an in-vitro diagnostic product." This is a direct declaration by the manufacturer.
- Components: The description mentions it contains "stabilized human or mammalian red blood cells, human, mammalian or simulated white blood cells and a platelet component." These are biological components used in the calibration process for a blood analyzer.
- Storage Conditions: The specified storage conditions (2 - 10° C) are typical for biological reagents and calibrators used in IVD testing.
- Performance Studies: The performance studies described (Run-to-Run Reproducibility, Closed-Vial Stability, Open-Vial Stability, Calibrator Performance Verification, and Calibration Equivalency) are all standard types of studies conducted to validate the performance of an IVD calibrator.
- Predicate Device: The mention of a predicate device (Cal-Chex, K840261) which is also a calibrator for a hematology analyzer, further supports its classification as an IVD.
Therefore, based on the provided information, the CELL-DYN 22 Plus Calibrator is definitively an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system.
Assayed parameters include: WBC (109/L), RBC (1012/L), HGB (g/dL), MCV (fL), PLT (108/L)
Product codes
KRX
Device Description
CELL-DYN 22 Plus Calibrator is an in-vitro diagnostic product that may contain any or all of the following: stabilized human or mammalian red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium. The product is packaged in polypropylene plastic vials containing 2.5ml. The closures are polypropylene screw caps with polyethylene liners. The vials will be packaged in a four (4) welled vacuum formed clamshell 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
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Summary of Performance Studies
Five types of studies were conducted to establish performance of CELL-DYN 22 Plus Calibrator. The five tests conducted were Run-to-Run Reproducibility, Closed-Vial Stability, Open-Vial Stability, Calibrator Performance Venfication and Calibration Equivalency. All testing showed that CELL-DYN 22 Plus Control is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.8150 Calibrator for cell indices.
(a)
Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). 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
KIII204
510(k) Summary of Safety and Effectiveness
DEC 2 2 2011
, İ
| 510(k) Submitter: | Streck |
|---|---|
| 7002 South 109th Street | |
| Omaha, NE 68128 | |
| Official Correspondent: | Bert Moses, Director of Quality |
| (402) 537-5343 | |
| Date Prepared: | April 12, 2011 |
| Name of Device: | |
| Trade Name: | CELL-DYN 22 Plus Calibrator |
| Common Name: | Assayed Hematology Calibrator |
| Classification Name: | Calibrator for Cell Indices (864.8150) |
| Predicate Device: | Cal-Chex (K840261) Manufactured by Streck |
Description:
CELL-DYN 22 Plus Calibrator is an in-vitro diagnostic product that may contain any or all of the following: stabilized human or mammalian red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium. The product is packaged in polypropylene plastic vials containing 2.5ml. The closures are polypropylene screw caps with polyethylene liners. The vials will be packaged in a four (4) welled vacuum formed clamshell container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
Intended Use:
CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system.
Assayed parameters include: WBC (109/L), RBC (1012/L), HGB (g/dL), MCV (fL), PLT (108/L)
1
Comparison to Predicate Device:
| | Cal-Chex (Predicate
Product) | CELL-DYN 22 Plus Calibrator |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Statement | Cal-Chex is used to calibrate
multi-parameter hematology
analyzer | CELL-DYN 22 Plus Calibrator is
manufactured for calibration of the CELL-
DYN Emerald 22 system.
Assayed parameters include: WBC
(109/L), RBC (1012/L), HGB (g/dL), MCV
(fL), PLT (109/L) |
| Open Vial
Stability | 5 days | Same |
| Closed Vial
Stability | 45 days | Same |
| Reagents | The whole blood reagent may
contain any or all of the
following: stabilized human
or mammalian red blood cells,
human, mammalian or
simulated white blood cells
and a platelet component in a
preservative medium. | Same |
| Storage
Conditions | 2 - 10°C | Same |
Discussion of Tests and Test Results:
Five types of studies were conducted to establish performance of CELL-DYN 22 Plus Calibrator. The five tests conducted were Run-to-Run Reproducibility, Closed-Vial Stability, Open-Vial Stability, Calibrator Performance Venfication and Calibration Equivalency. All testing showed that CELL-DYN 22 Plus Control is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.
Conclusions Drawn From Tests:
Study results show CELL-DYN 22 Plus Calibrator to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. CELL-DYN 22 Plus Calibrator is a safe and effective product, which fulfills its intended use when used as instructed in the product information sheet.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Streck Inc. c/o Ms. Deborah S. Kipp Quality Assurance Coordinator 7002 South 109th Street Omaha, NE 68128
DEC 2 2 2011
Re: K111204
Trade/Device Name: CELL-DYN 22 Plus Calibrator Regulation Number: 21 CFR 864.8150 Regulation Name: Calibrator for cell indices Regulatory Class: Class II Product Code: KRX Dated: December 21, 2011 Received: December 22, 2011
Dear Ms. Kipp:
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
3
Page 2 - Ms. Deborah Kipp
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M. Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use Form
510(k) Number (if known):
Device Name: CELL-DYN 22 Plus Calibrator
Indications For Use:
CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system.
Assayed parameters include:
WBC (108/L), RBC (1012/L), HGB (g/dL), MCV (fL), PLT (108/L)
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)
Mana M. Chen
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111204
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