(49 days)
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No
The summary describes a tunable dual wavelength absorbance detector for laboratory use, with no mention of AI or ML capabilities, image processing, or data analysis methods that would typically involve AI/ML.
No
The device is a dual wavelength detector for laboratory use in quality assurance/control, methods development, and R&D. It is not intended for therapeutic purposes.
No
The device is described as a detector for Quality Assurance/Quality Control, methods development, and R&D in various laboratory and industrial settings. While it mentions hospitals as a potential facility, it explicitly states "The product is not intended exclusively for clinical use" and its listed applications do not involve diagnosing diseases or conditions in patients. Instead, it seems to be an analytical instrument for general laboratory work.
No
The device description explicitly states "Waters® 2487 Tunable Dual Wavelenqth Absorbance Dectector," indicating a hardware component (a detector) is the primary device. The intended use also describes a physical detector used in laboratory settings.
Based on the provided information, the Waters 2487 Dual Wavelength Detector is likely not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The primary intended uses are for routine Quality Assurance/Quality Control, methods development, and R&D in various laboratory settings (universities, industrial, pharmaceutical, manufacturing, analytical laboratories, and hospitals). While hospitals are mentioned, the use is not exclusively clinical. The emphasis is on general laboratory procedures for quality control and methods development.
- Lack of Specific Clinical Indication: There is no mention of diagnosing, monitoring, or treating any specific disease or condition using patient samples.
- General Laboratory Equipment: The description points to a general laboratory instrument for absorbance detection, a common technique in various analytical fields, not solely clinical diagnostics.
- No Mention of Patient Samples or Clinical Data: The description doesn't refer to analyzing patient samples or generating data for clinical decision-making.
While the device could potentially be used in a hospital laboratory, its stated intended uses and the lack of specific clinical indications strongly suggest it is a general-purpose laboratory instrument rather than a dedicated IVD.
N/A
Intended Use / Indications for Use
The Waters 2487 Dual Wavelength Detector is designed for the routine Quality Assurance/Quality Control laboratory as well as possessing features which would meet methods development and R&D requirements. Waters believes this detector will be utilized in both large and small facilities where high reliability, ease of training, start-up and operation, and design efficiency are important. These facilities may include Universities, industrial and pharmaceutical facilities, manufacturing facilities, analytical laboratories and hospitals.
The product is not intended exclusively for clinical use.
In using this product, the operator must follow generally accepted procedures for quality control and methods development.
Product codes
KZR
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
routine Quality Assurance/Quality Control laboratory; Universities, industrial and pharmaceutical facilities, manufacturing facilities, analytical laboratories and hospitals.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.2260 High pressure liquid chromatography system for clinical use.
(a)
Identification. A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.(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 stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 6 1997
Virqinia L. Corbin . Director, Regulatory Affairs Water Corporation 34 Maple Street Milford, Massachusetts 01757-3696
Re : K973074 Waters® 2487 Tunable Dual Wavelenqth Absorbance Dectector Regulatory Class: I Product Code: KZR Dated: August 13, 1997 Received: August 18, 1997
Dear Ms. Corbin:
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 The general controls provisions of the Act 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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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 caesgoriers 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 Also, please note the Office of Compliance at (301) 594-4639. 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 Butman
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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ATTACHMENT R
510(k) number (if known): .
Device Name: Waters® 2487 Dual Wavelength Detector
Indications For Use:
The Waters 2487 Dual Wavelength Detector is designed for the routine Quality Assurance/Quality Control laboratory as well as possessing features which would meet methods development and R&D requirements. Waters believes this detector will be utilized in both large and small facilities where high reliability, ease of training, start-up and operation, and design efficiency are important. These facilities may include Universities, industrial and pharmaceutical facilities, manufacturing facilities, analytical laboratories and hospitals.
The product is not intended exclusively for clinical use.
In using this product, the operator must follow generally accepted procedures for quality control and methods development.
(PLEASE DO NOI 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)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Num. K9935074