(103 days)
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No
The description focuses on a stabilized suspension for manual cell counting and differentiation, with no mention of automated analysis, algorithms, or learning processes.
No
This device is a control material used for monitoring cell counts and differentiation in body fluid samples, not a device used for treating diseases or conditions.
No
The device is an assayed control intended for monitoring and validating cell counts and differentiation in patient samples, not for diagnosing a condition itself. It is used to ensure the accuracy of diagnostic tests performed manually using a hemocytometer or Cytospin smears.
No
The device description clearly states that Cell-Chex is a "stabilized suspension of human red blood cells, human white blood cells and monosodium urate crystals" packaged in "glass vials". This indicates a physical, biological control material, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that Cell-Chex is "intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples..." and "intended for monitoring white blood cell differentiation... in body fluid samples performed using Cytospin® smears." These are diagnostic procedures performed on samples taken from the human body.
- Device Description: The device is a "stabilized suspension of human red blood cells, human white blood cells and monosodium urate crystals... in a preservative medium." This is a reagent or control material used in laboratory testing.
- Function: The device is used to "validate quantitation" and "monitor" cell counts and differentiation in patient samples. This is a quality control function for in vitro diagnostic tests.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Cell-Chex fits this description as it is used to ensure the accuracy of diagnostic tests performed on patient samples.
N/A
Intended Use / Indications for Use
Cell-Chex is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains monosodium urate crystals which can be used to monitor the presence of crystals in synovial fluid.
Cell-Chex is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear: Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears.
Product codes
GLO
Device Description
Cell-Chex is a stabilized suspension of human red blood cells, human white blood cells and monosodium urate crystals (Level 1 only) in a preservative medium. The product is packaged in glass vials containing 2.0ml. The closures are polypropylene screw caps with polyethylene liners. There are two different levels. Level 1 contains a low cell count and monosodium urate crystals, and Level 2 contains a high cell count and no crystals. 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
Four types of studies were conducted to establish performance of Cell-Chex. The four tests conducted were Closed Vial Stability, Open Vial Stability, Run-to-Run Reproducibility, and Precision Performance Data. All testing showed that Cell-Chex is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck
7002 South 109th Street
Omaha, NE 68128 |
|-------------------------|----------------------------------------------------------------|
| Official Correspondent: | Kerrie Oetter, Regulatory Affairs Specialist
(402)-537-5215 |
| Date Prepared: | August 5, 2010 |
| Name of Device: | |
| Trade Name: | Cell-Chex™ |
| 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 |
AUG 2 3 2010#### Description:
Cell-Chex is a stabilized suspension of human red blood cells, human white blood cells and monosodium urate crystals (Level 1 only) in a preservative medium. The product is packaged in glass vials containing 2.0ml. The closures are polypropylene screw caps with polyethylene liners. There are two different levels. Level 1 contains a low cell count and monosodium urate crystals, and Level 2 contains a high cell count and no crystals. 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 is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains monosodium urate crystals which can be used to monitor the presence of crystals in synovial fluid.
Cell-Chex is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear: Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears.
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Comparison to Predicate Device:
| | Cell-Chex - original (Predicate
Product) | Cell-Chex - New with crystal |
|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Statement | Cell-Chex is an assayed control
intended for monitoring total cell
counts performed manually using a
hemocytometer to validate
quantitation of red and white
blood cells in patient
cerebrospinal fluid and body
samples including pleural,
pericardial, peritoneal and
synovial fluid. It is also intended
for monitoring white blood cell
differentiation in body fluid
samples performed using
Cytospin smears. | Cell-Chex is an assayed control
intended for monitoring total cell
counts performed manually using a
hemocytometer to validate
quantitation of red and white blood
cells in patient cerebrospinal fluid
and body fluid samples including
pleural, pericardial, peritoneal and
synovial fluid. Level 1 contains
monosodium urate crystals which
can be used to monitor the
presence of crystals in synovial
fluid.
Cell-Chex is also intended for
monitoring white blood cell
differentiation (Mononuclear,
Ploymorphonuclear; Neutrophils,
Eosinophils, Basophils,
Lymphocytes and Monocytes) in
body fluid samples performed using
Cytospin® smears. |
| Open Vial
Stability | 30 days | Same |
| Closed Vial
Stability | 6 months | 60 days |
| Reagents | Stabilized human red blood cells
and human white blood cells in a
preservative medium. | Stabilized human red blood cells,
human white blood cells and
monosodium urate crystals (Level 1
only) in a preservative medium. |
| Storage
Conditions | 2 - 10°C | Same |
| The only difference relative to the predicate product (i.e. Cell-Chex), which has been on | | |
the market since 2000 is the addition of the crystal component. The product composition and the associated product usage applications (i.e. hemacytometer and Cytospin™ smears) are unchanged. The crystal component is intended to be listed on the assay as positive or negative (i.e. present or not present).
Discussion of Tests and Test Results:
Four types of studies were conducted to establish performance of Cell-Chex. The four tests conducted were Closed Vial Stability, Open Vial Stability, Run-to-Run Reproducibility, and Precision Performance Data. All testing showed that Cell-Chex is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.
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Conclusions Drawn From Tests
Cell-Chex fulfills its intended use as a control mixture for manual counting of Red Blood Cells and White Blood Cells in body fluids such as cerebrospinal fluid. Results presented show it is consistently reproducible and performs comparably to the predicate product. It is safe and effective product when used as indicated in instructions for use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Streck c/o Ms. Kerrie Oetter Regulatory Affairs Specialist 7002 South 109th Street Omaha, NE 68128
AUG 2 3 2010
Re: K101335
Trade/Device Name: Cell-Chex™ Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GLO Dated: July 26, 2010 Received: July 27, 2010
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 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
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Page 2 - Ms. Kerrie Oetter
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.
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/ReportalProblem/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,
ia m. Chen
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
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Indication for Use Form
510(k) Number (if known): K101335
Device Name: Cell-Chex™ AUG 2 3 2010
Indications For Use:
Cell-Chex is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, peritoneal and synovial fluid. Level 1 contains monosodium urate crystals which can be used to monitor the presence of crystals in synovial fluid.
Cell-Chex is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in
body fluid samples performed using Cytospin® smears
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)
Maria M. Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101335
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