(160 days)
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No
The description focuses on automated laboratory procedures (pipetting, heating, measuring color intensity) and standard chemical analysis, with no mention of AI or ML algorithms for data interpretation, pattern recognition, or decision support.
No
The device is a chemistry analyzer and reagents used for diagnostic purposes by measuring analytes in samples; it does not directly treat or prevent a disease.
Yes
The device is intended to measure various analytes in biological samples, and these measurements are "used in the diagnosis and treatment of numerous diseases." This directly aligns with the definition of a diagnostic device.
No
The device description clearly states it is a "discrete photometric chemistry analyzer" that performs physical actions like pipetting, heating, and measuring color intensity, indicating it is a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "clinical use" and is used to "measure a variety of analytes of clinical interest in serum, plasma samples." This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description details how the device performs analytical procedures on samples, which is a core function of an IVD.
- Associated Reagents: The description of the associated reagents (Calibrator, Albumin, ALT, Glucose, BUN) further confirms the IVD nature. These reagents are specifically designed to be used with the analyzer to perform diagnostic tests on biological samples. The intended use of each reagent also clearly states their purpose in measuring specific analytes for diagnostic and treatment purposes.
Therefore, based on the provided information, the TC Matrix Clinical Chemistry Analyzer and its associated reagents are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
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.
Product codes
CGA, CKA, CIX, CDQ, JJE, JIX
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Teco Diagnostics c/o Ms. Jian Vaeches R & D Department 1268 North Lakeview Avenue Anaheim, CA 92807
MAY - 8 2008
K073370 Re:
Trade Name: TC Matrix Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, CKA, CIX, CDQ, JJE, JIX Dated: March 12, 2008 Received: March 24, 2008
Dear Ms. Vaeches:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your booms in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regarly manative to of the Medical Device American Drug commerce prof to May 20, 1770, the chaomen and the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costletic Act (Act) that to not roquire approvine of the general controls provisions of the Act. The Act. The You may, merelore, market the device, basyon to me ments for annual registration, listing of general controls provisions of the recess labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (soo aoove) inro . Existing major regulations affecting your device It may be subject to such additional comeonal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Title 21, Codo of Federal resguents.
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 Please be advised that I DA s issualled of a but one complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a determination and Jour Stered by other Federal agencies. You must in and lisit of any Federal statutes and regulations annings, but not limited to: registration and listing (21 comply with an the Ace 3 requirements, includes 3).
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), laboning (21 Ce quality systems (QS) regulation (21 CFR Part 820).
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Coopes, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (If Known) :
Device Name: TC Matrix Clinical Chemistry Analyzer
Indications for Use:
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.
Prescription Use J ___________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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