(72 days)
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No
The description focuses on the device being a stabilized suspension for manual cell counting and crystal monitoring, with no mention of automated analysis, image processing, or AI/ML terms.
No
The device is described as an assayed control for monitoring cell counts and crystal presence in patient samples, indicating it is an in vitro diagnostic control material, not a therapeutic device.
No
This device is an assayed control intended for monitoring and validating laboratory procedures (total cell counts, cell differentiation) rather than directly diagnosing a patient's condition. It ensures the accuracy of other diagnostic tests.
No
The device description clearly states it is a "stabilized suspension of human red blood cells, human white blood cells and calcium pyrophosphate dihydrate (CPPD) Crystals in a preservative medium," 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 the device 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 all diagnostic procedures performed in vitro (outside the body) on patient samples.
- Device Description: The device is a "stabilized suspension of human red blood cells, human white blood cells and calcium pyrophosphate dihydrate (CPPD) Crystals... in a preservative medium." This is a control material used in laboratory testing.
- Performance Studies: The performance studies described (Closed Vial Stability, Open Vial Stability, Run-to-Run Reproducibility, and Precision Performance) are typical studies conducted to validate the performance of an IVD control material.
- Predicate Device: The predicate device listed (K101335; Cell-Chex™) is also a control material used in laboratory testing, further indicating that this device falls under the IVD category.
The device is used in vitro to assess the performance of diagnostic tests (manual cell counts and white blood cell differentiation) performed on patient samples. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cell-Chex™ with CPPD Crystals 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 calcium pyrophosphate dihydrate (CPPD) Crystals, which can be used to monitor the presence of crystals in synovial fluid.
Cell-Chex™ with CPPD Crystals 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 (comma separated list FDA assigned to the subject device)
GLQ
Device Description
Cell-Chex™ with CPPD Crystals is a stabilized suspension of human red blood cells, human white blood cells and calcium pyrophosphate dihydrate (CPPD) 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 polvethylene liners. There are two different levels. Level 1 contains a low cell count and CPPD 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 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
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Input Imaging Modality
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Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Four types of studies were conducted to establish performance of Cell-Chex with CPPD Crystals. The four tests conducted were Closed Vial Stability, Open Vial Stability, Runto-Run Reproducibility, and Precision Performance. All testing showed that Cell-Chex™ with CPPD crystals is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.
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.
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MAY 2 6 2011
510/k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck
7002 South 109th Street
Omaha, NE 68128 |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Deborah Kipp, Quality Assurance Coordinator
(402) 537-5215 |
| Date Prepared: | March 14, 2011 |
| Name of Device:
Trade Name:
Common Name:
Classification Name: | Cell-Chex™ with CPPD Crystals
Hematology Control for Body Fluids
Hematology Quality Control Mixture (864.8625) |
| Predicate Device: | Cell-Chex™ (K101335) Manufactured by Streck |
Description:
Cell-Chex™ with CPPD Crystals is a stabilized suspension of human red blood cells, human white blood cells and calcium pyrophosphate dihydrate (CPPD) 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 polvethylene liners. There are two different levels. Level 1 contains a low cell count and CPPD 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 clamshell container with the package insert / assay sheet. The product must be stored at 2 - 10°C.
Intended Use:
Cell-Chex™ with CPPD Crystals 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 calcium pyrophosphate dihydrate (CPPD) Crvstals which can be used to monitor the presence of crystals in synovial fluid.
Cell-Chex™ with CPPD Crystals 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.
1
Comparison to Predicate Device:
| Cell-Chex™ (Predicate Product) | Cell-Chex™ with CPPD Crystals | |
|---|---|---|
| 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 fluid | ||
| samples including pleural, pericardial, | ||
| peritoneal and synovial fluid. Level 1 | ||
| contains monosodium urate crystals which | Cell-Chex™ with CPPD Crystals 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 calcium pyrophosphate | ||
| 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. | dihydrate (CPPD) crystals, which can be | |
| used to monitor the presence of crystals in | ||
| synovial fluid. | ||
| Cell-Chex™ with CPPD Crystals is also | ||
| intended for monitoring white blood cell | ||
| differentiation (Mononuclear, | ||
| Polymorphonuclear; Neutrophils, | ||
| Eosinophils, Basophils, Lymphocytes and | ||
| Monocytes) in body fluid samples performed | ||
| Open Vial | ||
| Stability | 30 days | using Cytospin® smears. |
| Same | ||
| Closed Vial | ||
| Stability | 60 days | Same |
| Reagents | Stabilized human red blood cells, human | |
| white blood cells and monosodium urate | ||
| crystals (Level 1 only) in a preservative | ||
| medium. | Stabilized human red blood cells, human | |
| white blood cells CPPD 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™) is the substitution of the | ||
| inert CPPD crystal component for the inert urate crystals in the Level 1 control. Level 2 | ||
| contains the same formulation as Cell-Chex™ (K101335). The product composition and the | ||
| associated product usage applications (i.e. hemocytometer and Cytospin® smears) are | ||
| unchanged. The CPPD crystal component is intended to be listed on the assay as positive or |
Discussion of Tests and Test Results:
negative (i.e. present or not present).
Four types of studies were conducted to establish performance of Cell-Chex with CPPD Crystals. The four tests conducted were Closed Vial Stability, Open Vial Stability, Runto-Run Reproducibility, and Precision Performance. All testing showed that Cell-Chex™ with CPPD crystals 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™ with CPPD Crystals 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 compably to the predicate product. Cell-Chex™ with CPPD Crystals is a safe and effective product when used as indicated in the 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 depiction of an eagle or bird-like figure 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Streck. Inc. c/o Ms. Deborah Kipp Quality Assurance Coordinator 7002 South 109th Street Omaha. NE 68128
Re: K110718
Trade/Device Name: Cell-Chex™ with CPPD Crystals Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GLQ Dated: March 14, 2011 Received: March 15, 2011
MAY 2 6 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 will allow you to begin marketing your device as described in your Section 510(k) premarket
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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 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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Indications for Use Form
510(k) Number (if known): K | | 07718
Device Name:
Cell-Chex™ with CPPD Crystals
Indications For Use:
Cell-Chex™ with CPPD Crystals 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 plural, pericardial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dihydrate (CPPD) Crystals, which can be used to monitor the presence of crystals in svnovial fluid.
Cell-Chex™ with CPPD Crystals is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, 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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110718
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