(112 days)
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No
The summary describes an automated microtiter plate processor and reader that measures light absorbance or luminescence. There is no mention of AI, ML, or any related terms, nor is there any description of image processing or data analysis that would typically involve AI/ML. The focus is on automation of a standard laboratory process.
No
Explanation: The device is described as an automated microtiter plate processor and reader that measures light absorbance or luminescence of reaction products, indicating it is an in-vitro diagnostic device used for laboratory analysis, not a device directly used for therapy.
No
The device is described as automating the processing and reading of microtiter plates by measuring light absorbance or luminescence of reaction products. While this data could be used in diagnostics, the device itself is a measurement tool and does not provide a diagnosis. Its intended use states "automate microtiter plate processor and reader that measures...", implying a role in laboratory analysis rather than diagnostic output.
No
The device description explicitly states it is an "Automated Microtiterplate Processor and Reader," which are hardware components used to measure light absorbance or luminescence. This indicates it is a physical device, not software only.
Based on the provided information, the ALPHA 4 LS device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to "automate microtiter plate processor and reader that measures the light absorbance or luminescence of reaction products". This strongly suggests it's used to analyze biological samples (like blood, urine, or other bodily fluids) which are typically processed in microtiter plates to detect or measure specific substances or reactions.
- Input Imaging Modality: "Light Aborbance or Luminescence" are common methods used in IVD assays to quantify the results of biochemical or immunological reactions.
- Intended User / Care Setting: "Clinical Laboratory" is the typical setting where IVD testing is performed.
While the description doesn't explicitly state it analyzes human samples, the combination of microtiter plate processing, measurement of reaction products using light absorbance/luminescence, and use in a clinical laboratory setting are all hallmarks of an IVD device.
The lack of information about image processing, AI/ML, patient age range, and performance studies doesn't negate its likely IVD status. Many IVD devices don't utilize these technologies or require specific patient age ranges for their intended use.
N/A
Intended Use / Indications for Use
THE ALPHA 4 LS MICROTITER PLATE PROCESSOR AND READER IS INTENDED TO MEASURE THE LIGHT ABORBANCE OR LUMINESCENCE IN MICRO TITER PLATE REACTION PRODUCTS IN EITHER MODE.
Product codes
JJQ
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 (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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§ 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
(a)
Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.(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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
FEB - 4 19
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward J. Doyle General Manager & Corporate Secretary SFRI, Inc. 2082 Michelson Drive, Suite 100 Irvine, California 92612-1212
Re : K973938 R175930
Alpha 4 LS Automated Microtiterplate Processor and Reader Requlatory Class: I Product Code: JJQ Dated: December 29, 1997 Received: January 6, 1998
Dear Mr. Doyle:
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 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 Bitman
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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K973938/A002/
Page of
510(k) Number (if known): 67393938 MICRO TITER PLATE ARTOMATED ﮯ ﮐﮯ ALPHA 4 AND READER Device Name:_ PROCESSOR GENERAL Indications For Use: THE ALPHA 4 LS INTENDED THE PATITER PLATE PROCESSOR AND THE ALPHA 4 LS IS TO MICROTITER PLATE AUTOMATES MICH. REACTION PRODUCTS IN THAT MEASURES IS .
THE LIGHT ABORBANCE OR LUMINESCENCE READER EITHER MODE
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973938
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
FEREED NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Prescription Coll.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)