(237 days)
Not Found
No
The device is a hematology control material used for calibrating and evaluating the performance of a hematology analyzer. The description focuses on the composition, packaging, storage, and stability of the control material, with no mention of AI or ML for data analysis or interpretation.
No
This device is an in-vitro diagnostic control for evaluating the accuracy and precision of a hematology system, not for treating patients.
No
The device is described as a control material used to evaluate the accuracy and precision of an analytical system (CELL-DYN Emerald 22), not to directly diagnose a patient's medical condition. It's an "in-vitro diagnostic product" but specifically for quality control of another diagnostic device.
No
The device description clearly states it is an "in-vitro diagnostic product that contains stabilized human red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium," and is packaged in physical vials. This indicates a biological and physical component, 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 for "evaluating the accuracy and precision of the CELL-DYN Emerald 22 system." This system is a hematology analyzer, which is used to perform diagnostic tests on blood samples. The control is used to ensure the accuracy of these diagnostic tests.
- Device Description: The device description clearly states, "CELL-DYN 22 Plus Control is an in-vitro diagnostic product..."
- Components: The product contains stabilized human red blood cells, human, mammalian or simulated white blood cells, and a platelet component. These are biological components used in laboratory testing.
- Storage: The storage requirements (2 - 10° C) are typical for biological reagents used in IVD testing.
- Performance Studies: The performance studies described (stability, reproducibility, external site recovery) are standard types of studies conducted to validate the performance of IVD products.
- Predicate Device: The predicate device listed (K901875; Para 12 Plus) is also a hematology control, which is a type of IVD.
All of these factors indicate that the CELL-DYN 22 Plus Control is a product intended for use in an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system.
Assayed parameters include:
WBC (108/L), RBC (1013L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10°/L), MPV (iL), NEU (%), NEU (10°/L), LYM (%), LYM (10°/L), MON (10°/L), EOS (%), EOS (10°/L), BAS (%), BAS (10°/L)
Product codes (comma separated list FDA assigned to the subject device)
GLQ
Device Description
CELL-DYN 22 Plus Control is an in-vitro diagnostic product that contains stabilized human 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. There are three different levels (low, normal and high). 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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Five types of studies were conducted to establish performance of CELL-DYN 22 Plus Control. The five tests conducted were Closed-Vial Stability, Open-Vial Stability, 10-Run Reproducibility, 10-Run Reproducibility compared with Whole Blood and External Site recovery of values. 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
DEC 2 2 2011
| 510(k) Submitter: | Streck
7002 South 109th Street
Omaha, NE 68128 |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Bert Moses, Director of Quality
(402)537- 5343 |
| Date Prepared: | April 14, 2011 |
| Name of Device:
Trade Name:
Common Name:
Classification Name: | CELL-DYN 22 Plus Control
Assayed Hematology Control
Hematology quality control mixture (864.8625) |
| Predicate Device: | Para 12 Plus (K901875) Manufactured by Streck |
Description:
CELL-DYN 22 Plus Control is an in-vitro diagnostic product that contains stabilized human 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. There are three different levels (low, normal and high). 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-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system.
Assayed parameters include:
WBC (108/L), RBC (1013L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10°/L), MPV (iL), NEU (%), NEU (10°/L), LYM (%), LYM (10°/L), MON (10°/L), EOS (%),
EOS (10°/L), BAS (%), BAS (10°/L)
| Para 12 Plus (Predicate Product) | CELL-DYN 22 Plus Control | |
|---|---|---|
| Intended Use | ||
| Statement | Para 12 Plus is an assayed | |
| hematology control for evaluating | ||
| the accuracy and precision of | ||
| hematology instruments that provide | ||
| a white blood cell differential. | CELL-DYN 22 Plus Control is an | |
| assayed hematology control for | ||
| evaluating the accuracy and precision | ||
| of the CELL-DYN Emerald 22 system. |
Assayed parameters include:
$WBC (10^9/L), RBC (10^{12}/L), HGB$
(g/dL), HCT (%), MCV (fL), MCH (pg),
MCHC (g/dL), RDW (%), PLT $(10^9/L)$ ,
MPV (fL), NEU (%), NEU $(10^9/L)$ , LYM
(%), LYM $(10^9/L)$ , MON (%), MON
$(10^9/L)$ , EOS (%), EOS $(10^9/L)$ , BAS
(%), BAS $(10^9/L)$ |
| Open Vial Stability | 7 days | 8 days |
| Closed Vial Stability | 75 days | Same |
Comparison to Predicate Device:
1
| 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 Control. The five tests conducted were Closed-Vial Stability, Open-Vial Stability, 10-Run Reproducibility, 10-Run Reproducibility compared with Whole Blood and External Site recovery of values. 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 Control to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating. CELL-DYN 22 Plus Control is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
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 2011
Re: K111211
Trade/Device Name: CELL-DYN 22 Plus Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GLQ 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 mchen
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):
K///2//
Device Name: CELL-DYN 22 Plus Control
Indications For Use:
CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system.
Assayed parameters include:
WBC (108/L), RBC (1012/L), HGB (g/dL), HCT (%), MCV (pg), MCHC (g/dL), RDW (%), PLT (10%L), MPV (fL), NEU (%), NEU (10%L), LYM (%), LYM (109%), MON (108%), EOS (%), EOS (10°/L), BAS (%), BAS (10°/L)
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)
m. Chen
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111211
Page 1 of 1