(24 days)
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No
The description focuses on standard laboratory instrument functionality (measuring light, converting to electrical signals, reporting RLUs) and mentions calculations and interpretations based on "assay validation parameters," which are typically pre-defined rules, not learned algorithms. There is no mention of AI, ML, or related concepts.
No
The device measures light from chemical reactions to calculate and interpret assay results, which is a diagnostic function, not a therapeutic one. It does not treat or cure any medical condition.
No
The device measures light emitted from chemical reactions and converts it into relative light units, which are then used in calculations. It does not directly diagnose; it is a tool in a diagnostic process.
No
The device description clearly describes a physical hardware device (microplate luminometer) with components like stepper motors, a photomultiplier tube, and an electrical amplifier, which measures light from a chemical reaction. While it is controlled by a personal computer, the core function and components are hardware-based.
Based on the provided information, the Digene DML 2000 Microplate Luminometer is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for measuring light emitted from a chemiluminescent reaction, and that "Assay results obtained using chemiluminescence technology in 96 well microplates are calculated and interpreted according to assay validation parameters." This strongly suggests the device is used in conjunction with assays to obtain results that are then interpreted, which is a core function of IVD devices.
- Device Description: The description details how the device measures light from chemical reactions in microplates and reports results in Relative Light Units (RLU). This process is typical for many IVD assays that utilize chemiluminescence for detection and quantification of analytes in biological samples.
- Predicate Device: The mention of a predicate device (K962265; MLX Microtiter® Plate Luminometer) is a strong indicator that this device is being submitted for regulatory clearance as an IVD. Predicate devices are typically other legally marketed IVD devices that the new device is being compared to.
While the document doesn't explicitly state "In Vitro Diagnostic," the combination of the intended use for measuring and interpreting assay results from chemical reactions in a laboratory setting, and the reference to a predicate device that is also a microplate luminometer, points overwhelmingly towards it being an IVD device.
N/A
Intended Use / Indications for Use
The Digene DML 2000 Microplate Luminometer is intended to measure light that is emitted as a result of a chemiluminescent reaction. Assay results obtained using chemiluminescence technology in 96 well microplates are calculated and interpreted according to assay validation parameters.
Product codes (comma separated list FDA assigned to the subject device)
KHO, JJQ
Device Description
The DML 2000 is a microplate luminometer capable of reading chemiluminescence from opaque microplates. Chemiluminescence is the production of light from a chemical reaction. The luminometer is optimally designed for measurement of glow type luminescence. The luminometer is designed to be run and controlled by a personal computer connected via a serial RS-232 interface port. The instrument is simple in design with measurement taking place in 96-well microplates, where each well is presented to the detector by stepper motors moving the plate. The light is detected by a photomultiplier tube. The light is amplified and converted to an electrical signal which is detected by a sensitive electrical amplifier. The detected signals are converted to Relative Light Units (RLU) and are reported for each well of the microplate. Assay results are calculated and interpreted according to assay validation parameters.
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.
MLX Microtiter® Plate Luminometer (K962265)
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/0 description: The image shows a logo with a black circle on the left, followed by a stylized text "DIGENE" in black. The text is bold and has a modern, geometric design. Below the logo and text, there is an address "9000 Virginia Manor Road" in a smaller font size.
Image /page/0/Picture/1 description: The image shows the text "K9 80120" on the first line and "Feb. 6, 1998" on the second line. The text is written in a handwritten style. The first line appears to be a code or identification number, while the second line represents a date.
1000 Virginia Manor Road
Beltsville, Maryland 20705
(301) 470-6500
FAX (301) 470-6498
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Submitter's Name, Address, Telephone and Facsimile Numbers, Contact Person, and Date Prepared:
Submitter Digene Corporation 9000 Virginia Manor Road, Suite 207 Beltsville, MD 20705 Phone: 301-470-6500 301-470-2881 Facsimile:
Contact Person Constance A. Finch, Dr.P.H. Director of Regulatory and Clinical Affairs Digene Corporation Phone: 301-470-6557 Facsimile: 301-470-2881
Date Prepared: January 12, 1998
| Trade Name: | Digene DML 2000TM Microplate Luminometer |
|---|---|
| Common or Usual Name: | Luminometer |
| Classification Name: | Colorimeter, photometer, or spectrophotometer for clinical use |
| Predicate Device: | MLX Microtiter® Plate Luminometer (K962265) |
| Dynatech Laboratories |
Image /page/0/Picture/11 description: The image shows the numbers 687 over 641. The numbers are handwritten and appear to be part of a mathematical equation or calculation. The number 687 is written in a cursive style, while the number 641 is in a more standard font.
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Image /page/1/Picture/0 description: The image shows a logo with a black circle on the left, followed by a stylized text. The text appears to be the word "DICINE" in a bold, blocky font, with some geometric shapes incorporated into the letters. The overall design is simple and modern, with a focus on strong visual elements.
9000 Virginia Manor Road
Beltsville, Maryland 20705
(301) 470-6500
FAX (301) 470-6498
Device Description:
The DML 2000 is a microplate luminometer capable of reading chemiluminescence from opaque microplates. Chemiluminescence is the production of light from a chemical reaction. The luminometer is optimally designed for measurement of glow type luminescence. The luminometer is designed to be run and controlled by a personal computer connected via a serial RS-232 interface port. The instrument is simple in design with measurement taking place in 96-well microplates, where each well is presented to the detector by stepper motors moving the plate. The light is detected by a photomultiplier tube. The light is amplified and converted to an electrical signal which is detected by a sensitive electrical amplifier. The detected signals are converted to Relative Light Units (RLU) and are reported for each well of the microplate. Assay results are calculated and interpreted according to assay validation parameters.
Intended Use:
The Digene DML 2000 Microplate Luminometer is intended to measure light that is emitted as a result of a chemiluminescent reaction. Assay results obtained using chemiluminescence technology in 96 well microplates are calculated and interpreted according to assay validation parameters.
Technological Characteristics:
The Digene DML 2000 Microplate Luminometer is substantially equivalent in terms of intended use and principles of operation to the MLX® Microtiter Plate Luminometer manufactured by Dynatech Laboratories. Both devices are intended for the measurement of light produced by chemiluminescence. There are no differences in technological features that raise new or different issues regarding safety or effectiveness. The DML 2000 does not have any direct patient contact or otherwise perform any therapeutic patient function. The DML 2000 measures the light produced by chemiluminescent reactions and provides test results in a spreadsheet format.
The Digene software incorporated in the DML 2000 was developed and manufactured in accordance with comprehensive software development, validation and verification procedures.
The DML 2000 conforms to safety and environmental standards relevant to luminometers. A hazard analysis has been performed and all known hazards are adequately addressed by device design or user instructions.
688
642
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Image /page/2/Picture/2 description: The image shows a partial view of the Department of Health & Human Services logo. The text "DEPARTMENT OF HEALTH & HL" is visible, arranged in a circular pattern around a seal. To the right of the text and seal is a stylized symbol featuring three human profiles facing right, stacked on top of each other.
FEB - 6 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Constance A. Finch, Dr.P.H. Director of Requlatory and Clinical Affairs Digene Corporation 9000 Virginia Manor Road Beltsville, Maryland 20705
Re : K980120 Digene DML 2000™ Microplate Luminometer Regulatory Class: I Product Code: KHO, JJQ Dated: January 12, 1998 Received: January 13, 1998
Dear Ms. Finch:
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 Regulations, Title 21, Parts 800 to 895. ಡಿ 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 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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INDICATIONS FOR USE STATEMENT
510(K) Number (if known): K980120
Device Name: Digene DML 2000 Microplate Luminometer
Indications for Use: The Digene DML 2000 Microplate Luminometer is intended to measure light that is emitted as a result of a chemiluminescent reaction. Assay results obtained using chemiluminescence technology in 96 well microplates are calculated and interpreted according to assay validation parameters.
(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)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) (Division of Clinical Laboratory Device 510(k) Number