(127 days)
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No
The summary describes a standard in vitro diagnostic instrument for measuring enzyme activity, with no mention of AI or ML terms, image processing, or data training/testing.
No
This device is an in vitro diagnostic instrument used to measure enzyme activity for the diagnosis and treatment of diseases; it does not directly treat or alleviate a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that it is an "in vitro diagnostic instrument and procedure."
No
The device is described as an "in vitro diagnostic instrument and procedure," which clearly indicates it includes hardware components for measuring enzyme activity in biological samples.
Yes, based on the provided information, the Polymedco SpotChem EX and ALT test system is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is an "in vitro diagnostic instrument and procedure."
- Measurement of Analytes: It is intended to measure the activity of the enzyme alanine amino transferase (ALT) in biological samples (serum, plasma, and whole blood). This is a key characteristic of IVD devices.
- Diagnostic Purpose: The measurements are used "in the diagnosis and treatment of certain liver diseases... and heart diseases." This clearly indicates a diagnostic purpose.
Therefore, the device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Polymedco SpotChem EX and ALT test system is an in vitro diagnostic instrument and procedure intended to measure the activity of the enzyme alanine amino transferase or ALT (also know as a serum glutamic pyruvic transaminase or SGPT) in serum, plasma and whole blood. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Product codes
CKA, JJF
Device Description
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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
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Key Metrics
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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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§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro 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. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 4 2005
Mr. Yuji Yagi ARKRAY, Inc. 57 Nishiaketa-Cho. Higashi-Kujo, Minami-Ku Kyoto, Japan 601-8045
K040332 Trade/Device Name: SpotChem EZ Analyzer and ALT Test Regulation Number: 21 CFR 862.1030 Regulation Name: Alanine amino transferase (ALT/SGPT) test system Regulatory Class: Class I Product Code: CKA, JJF Dated: April 6, 2004 Received: April 27, 2004
Dear Mr. Yagi:
Re:
This letter corrects our substantially equivalent letter of April 6, 2004 regarding the applicant/ owner which should be listed as Arkray and not Polymedco.
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 (Act 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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations and to 895. In additions and to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 not 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); 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 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)276-0484. 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 the more of (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Cornelia B. Pookt
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
Cc: Polymedco, Inc Helen Landicho, RAC
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Indications for Use
510(k) Number (if known): K040332
Device Name:_SpotChem EZ Analyzer and ALT Test
Indications For Use:
The Polymedco SpotChem EX and ALT test system is an in vitro diagnostic instrument and procedure intended to measure the activity of the enzyme alanine amino transferase or ALT (also know as a serum glutamic pyruvic transaminase or SGPT) in serum, plasma and whole blood. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Prescription Use V (Part 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)
Carol C Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040332
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