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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.

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.

The provided text describes the Cell-Chex™ with CPPD Crystals device, its intended use, and a comparison to a predicate device (Cell-Chex™). It also mentions the types of studies conducted to establish its performance. However, it does not explicitly state "acceptance criteria" in a quantitative format or report specific numerical performance metrics against those criteria. Instead, the studies aim to demonstrate reproducibility, substantial equivalence to the predicate, and stability.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria. Instead, it frames the success of the studies in terms of "consistently reproducible," "substantially equivalent to the predicate product," and "stable for the shelf life claimed."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes used for the "Closed Vial Stability," "Open Vial Stability," "Run-to-Run Reproducibility," and "Precision Performance" studies. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not describe the use of experts or the establishment of ground truth in the context of clinical or diagnostic performance for the test set. The device is a "Hematology Quality Control Mixture," meaning its "ground truth" (i.e., its expected cell counts and crystal presence) is internally derived from its manufacturing specifications and assessed through analytical studies, rather than by expert interpretation of patient samples.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for this control device is based on its composition and manufacturing specifications, not on expert adjudication of diagnostic images or clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a hematology quality control mixture, not an AI or imaging device requiring human reader interpretation or assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a laboratory control, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device is its manufactured composition and stability characteristics. For example, Level 1 contains CPPD crystals, and its expected cell counts (low count) are inherent to its design as a control. The studies focused on confirming that these inherent properties are maintained over time (stability) and are consistently met across manufacturing runs (reproducibility and precision).

8. The Sample Size for the Training Set

Not applicable. This is a physical control product, not an AI/machine learning model that requires a training set. The studies described are analytical validation studies.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/machine learning model. The "ground truth" for the control material itself is established through its formulation, manufacturing process, and characterization by the manufacturer.

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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.

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.

The provided text describes the 510(k) submission for "Cell-Chex," a hematology control for body fluids. The device is intended for monitoring total cell counts and white blood cell differentiation using manual methods (hemocytometer and Cytospin® smears). The key change from the predicate device is the addition of monosodium urate crystals in Level 1 for monitoring crystal presence in synovial fluid.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for various performance metrics. Instead, it describes the types of studies conducted and their general conclusions. The "reported device performance" is qualitative, indicating the device meets its intended use and is comparable to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for the test sets used in the Closed Vial Stability, Open Vial Stability, Run-to-Run Reproducibility, or Precision Performance Data studies.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. Given the nature of a control device, the "data" would likely originate from internal testing conducted by the manufacturer (Streck).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for a test set in the traditional sense of clinical readings. This device is a control product, meaning its performance is evaluated against expected values for cell counts and crystal presence, not against expert interpretations of patient samples.

4. Adjudication Method for the Test Set

Since there were no human readers or expert interpretations of a test set of patient cases, an adjudication method like 2+1 or 3+1 is not applicable and therefore, not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically conducted for diagnostic devices where human interpretation directly impacts diagnosis and patient outcomes, and the AI is meant to assist human readers. Cell-Chex is a control used to validate the manual counting procedures, not a diagnostic AI system itself.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm was done. Cell-Chex is a physical control material and does not involve an algorithm with standalone performance. Its purpose is to provide known values for manual counting methods.

7. Type of Ground Truth Used

The "ground truth" for Cell-Chex's performance is established by its known, pre-defined characteristics as a control material. This includes:

• Expected cell counts (red blood cells, white blood cells).
• Expected white blood cell differentiation percentages.
• Presence or absence of monosodium urate crystals (for Level 1).

These values are determined during the manufacturing and characterization of the control product itself, rather than by expert consensus on external patient data or pathology. The studies (stability, reproducibility, precision) then verify that the product consistently maintains these known characteristics over time and across different manufacturing lots.

8. Sample Size for the Training Set

There is no mention of a training set sample size. This device does not involve a machine learning algorithm that requires training data.

9. How Ground Truth for the Training Set was Established

As there is no training set for a machine learning algorithm, this question is not applicable. The "ground truth" for the control material's inherent properties is established through the manufacturing process and quality control measures.

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Cell-Chex Auto is an assayed whole blood control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples.

Cell-Chex Auto 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 plastic vials containing 4ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels, Level 1 with a very low count, Level with a low count, and a Level 3 with a higher count. 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.

The provided text describes the 510(k) summary for the Cell-Chex Auto device. However, it does not contain specific acceptance criteria with numerical targets or a detailed study report that proves the device meets those criteria in the typical format of a clinical trial or performance study comparing against a gold standard with statistical measures.

Instead, the submission focuses on stability and reproducibility studies to demonstrate substantial equivalence to a predicate device.

Here's an attempt to extract the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Specified" due to the nature of this particular 510(k) submission:

Acceptance Criteria and Device Performance

The acceptance criteria are implied to be "consistent reproducibility" and "stability for the shelf life claimed," demonstrating substantial equivalence to the predicate device, iQ® Body Fluids Control (K051706). No specific numerical acceptance criteria (e.g., a target coefficient of variation, accuracy percentage, or confidence intervals) are explicitly stated in the provided text.

Detailed Study Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not specified in the provided text. The submission mentions "four types of studies" but does not detail the number of samples or runs performed for each.
   • Data Provenance: Not specified (e.g., country of origin). The studies were conducted by the manufacturer, Streck.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • Not Applicable. This device is a quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth for a test set. Its performance is evaluated based on its own stability characteristics and reproducibility when run on instruments, likely against a reference assay or manufacturer's target values rather than expert-derived ground truth.

3. Adjudication Method for the Test Set:

   • Not Applicable. (See point 2).

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. This type of study is typically for evaluating diagnostic imaging or pathology devices where multiple readers interpret cases. Cell-Chex Auto is a quality control material.
   • Effect Size: Not applicable.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance) Study:

   • Yes, implicitly. The studies described (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) assess the performance of the control material itself. While hematology instruments are involved, the focus is on the inherent characteristics of the Cell-Chex Auto product rather than a diagnostic algorithm or human interpretation. The "results consistency in the manufacture of Cell-Chex Auto" and its stability are the key performance indicators.

6. Type of Ground Truth Used:

   • Manufacturer's Reference Values / Established Stability Protocols: For a quality control material, the "ground truth" for stability and reproducibility studies typically refers to the manufacturer's established target values or range for the control material, and the adherence to pre-defined stability protocols (e.g., measuring values over time at specified conditions and comparing them to initial values or expected ranges). It is not pathology, expert consensus, or outcomes data in this context.

7. Sample Size for the Training Set:

   • Not Applicable. This device is a quality control material, not an AI/ML algorithm that requires a "training set." Its development involves formulation, manufacturing process control, and performance testing, not algorithmic training.

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. (See point 7).

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