Search Results

The TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.

TECO MULTI Calibrator is intended for the calibration of quantitative assays.

Teco Albumin reagent is intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Teco ALT reagent is intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Teco Glucose reagent is intended for the quantitative determination of total glucose in human serum or plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Teco BUN reagent is intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

The TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically various steps such as pipetting, heating, and measuring color intensity.

This FDA 510(k) clearance letter pertains to the TC Matrix Clinical Chemistry Analyzer and several associated reagents. It does not contain a study that proves the device meets acceptance criteria, nor does it provide details on specific acceptance criteria and device performance.

The letter primarily confirms that the FDA has reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. This determination is based on the indications for use stated in the enclosure.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided document.

Here's a breakdown of what can be inferred or is explicitly stated:

1. A table of acceptance criteria and the reported device performance:

• Not available in the provided document. The letter makes a determination of substantial equivalence based on the indications for use, but it does not present a table of specific performance criteria or the results of a study demonstrating these. Such information would typically be in the 510(k) submission itself, not the FDA's clearance letter.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not available in the provided document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not available in the provided document.

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/available. This device is a clinical chemistry analyzer, not an AI-assisted diagnostic imaging system that involves human readers in the way an MRMC study would measure.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable in the context of an "algorithm only". The device itself is an automated analyzer. Its performance is inherent to the analyzer's function, not a standalone "algorithm" in the typical sense of AI. The performance comparison would be between this analyzer and a predicate device or established reference methods. While the letter confirms substantial equivalence, it doesn't detail the studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not available in the provided document. For a chemistry analyzer, ground truth would typically be established by comparing results to a recognized reference method or a predicate device.

8. The sample size for the training set:

• Not applicable/available. As a clinical chemistry analyzer, this device does not typically have a "training set" in the machine learning sense. Its calibration and performance are established through analytical verification and validation studies using known controls, calibrators, and patient samples.

9. How the ground truth for the training set was established:

• Not applicable/available. See point 8.

Summary from the document:

• Device Name: TC Matrix Clinical Chemistry Analyzer
• Function: A discrete photometric chemistry analyzer intended to automate manual analytical procedures (pipetting, heating, measuring color intensity) for measuring various analytes in serum and plasma samples.
• Intended Use of specific reagents mentioned:
  • TECO MULTI Calibrator: For calibration of quantitative assays.
  • Teco Albumin reagent: To measure albumin concentration in serum and plasma for diagnosing liver or kidney diseases.
  • Teco ALT reagent: To measure alanine amino transferase (ALT) activity in serum and plasma for diagnosing liver and heart diseases.
  • Teco Glucose reagent: For quantitative determination of total glucose in human serum or plasma for diagnosing and treating carbohydrate metabolism disorders (e.g., diabetes mellitus).
  • Teco BUN reagent: To measure urea nitrogen in serum or plasma for diagnosing and treating renal and metabolic diseases.
• FDA Determination: Substantially equivalent to legally marketed predicate devices. This means the FDA believes it performs as intended and is as safe and effective as existing devices on the market for its stated indications.

Ask a specific question about this device