(63 days)
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No
The document describes a standard biochemistry analyzer and does not mention any AI or ML terms, image processing, or data analysis methods indicative of AI/ML.
No
The device is an in vitro diagnostic (IVD) instrument used to quantitate levels of constituents in bodily fluids, which is for diagnostic purposes, not therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Synermed® IR200™ analyzer is intended for in vitro diagnostic use."
No
The description clearly states the device is an "analyzer" and "instrument" intended for in vitro diagnostic use, which implies a physical hardware component for sample analysis. There is no mention of it being solely software.
Yes, based on the provided text, the Synermed® IR200™ analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- The Intended Use explicitly states: "The Synermed® IR200™ analyzer is intended for in vitro diagnostic use as a multiparameter biochemistry instrument..."
This statement directly identifies the device's purpose as being for in vitro diagnostic procedures.
N/A
Intended Use / Indications for Use
The Synermed® IR200™ analyzer is intended for in vitro diagnostic use as a multiparameter biochemistry instrument that sequentially quantitates levels of constituents in serum, plasma or urine. Testing is selective, i.e, only selected tests or profiles or automatic repeats of selected tests are performed on each sample.
The Synermed IR200 analyzer is specifically designed to perform tests with Synermed reagents or reagent applications recommended by Synermed. Consequently, no representation as to the general utility of the Synermed IR200 with other than Synermed reagents or approved applications is made and none should be inferred.
Product codes
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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three people.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 26 1997
Marcia J. Arentz · Vice President - Operations Synermed, Inc... .. 1688 50th Avenue Montreal (Lachine) , Quebec, Canada H8T 2V5
Re : K971491 IR200 Automated Chemistry Analyzer Requlatory Class: I Product Code: JJF Dated: April 23, 1997 Received: April 24, 1997
Dear Ms. Arentz:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requiation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page | 1 of 1 |
|---|---|
| 510(k) Number (if known): | Not Known K971491 |
| Device Name: | SYNERMED IR200 Chemistry Analyzer |
Indications For Use:
The Synermed® IR200™ analyzer is intended for in vitro diagnostic use as a multiparameter biochemistry instrument that sequentially quantitates levels of constituents in serum, plasma or urine. Testing is selective, i.e, only selected tests or profiles or automatic repeats of selected tests are performed on each sample.
The Synermed IR200 analyzer is specifically designed to perform tests with Synermed reagents or reagent applications recommended by Synermed. Consequently, no representation as to the general utility of the Synermed IR200 with other than Synermed reagents or approved applications is made and none should be inferred.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K971497
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
ﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
OR
Over-The-Counter Use
(Optional Format 1-2-96)