(58 days)
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No
The description details a spectrophotometer using optical measurements and a microprocessor with programmed software to perform calculations based on predefined standards. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
No.
The device is a spectrophotometer used for quantifying results of sperm analysis, not for treating any condition or disease.
Yes
The device quantifies results for sperm analysis, providing numerical analysis of sperm quantity or other ejaculate components. This analysis helps in understanding the state of a biological sample, which aligns with the definition of a diagnostic device. The comparison to the IVOS sperm analysis system further indicates its diagnostic application.
No
The device description explicitly states that the Automarqer™ contains an optical assembly, microprocessor, cassette position sensor, and readout screen, in addition to software. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the Automarqer™ is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states it's for "quantification of results using MARQTM Test Kits for sperm analysis." This involves analyzing a biological sample (sperm) outside of the body to provide information about a physiological state (sperm characteristics).
- Device Description: The description details how the device interacts with a "test cassette" containing "test reagents and sample suspension." It measures optical absorption in "DNA-specific dyes within the wells, generated by the staining reagents used in the MARQ test kits." This clearly describes a process of analyzing a biological sample using reagents, which is a hallmark of IVD devices.
- Performance Studies: The performance studies compare the Automarqer™ to the "IVOS sperm analysis system," which is listed as a predicate device with a K number (K920719). Predicate devices in regulatory submissions are typically other legally marketed IVD devices.
- Analysis of Biological Sample: The device analyzes "sperm or other sperm ejaculate component." This is a biological sample.
In summary, the Automarqer™ fits the definition of an IVD because it is a device intended for use in the examination of specimens derived from the human body (sperm) to provide information for diagnostic purposes (sperm analysis).
N/A
Intended Use / Indications for Use
The Automarqer™ is a differential spectrophotometer for quantification of results using MARQTM Test Kits for sperm analysis.
Product codes
GKZ
Device Description
The Automarqer™ is a differential spectrophotometer for quantification of results The ? Hatomarqo. - 115 Kits * for sperm analysis. The MARQ test kits employ a unique test cassette with four wells, each containing a filter to retain the test reagents and sample suspension. The test cassette is designed to be inserted into the Automarqer for reading of results after the sample has been processed. The Automarger provides the numeric analysis of the quantity of sperm or other sperm ejaculate component being evaluated.
The Automarger operates by measuring the well reflectivity in two wavelengths (red and green) and deriving the optical absorption in DNA-specific dyes within the wells, generated by the staining reagents used in the MARQ test kits. Each well emits a signal in the color with which it is illuminated (either red or blue dye). The first well of the test cassette provides a standard signal (using a standardized latex bead suspension), the second well provides a null signal, and the third and fourth wells provide sample signals.
The Automarqer contains an optical assembly, microprocessor and program, cassette position sensor and readout screen. Software in the microprocessor ROM directs the operations. The microprocessor detects position of the cassette as each well is inserted, stores the value of the signal from each well separately under red and green wavelength illuminations, and computes the corresponding reflectivity of the sample, using the scale defined by the difference between the first two wells (the standard signal and the null signal). In this way, the system is self-calibrating on each cassette.
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
Equivalent results are obtained on semen samples analyzed by both the Automarqer™ and the IVOS sperm analysis system. Only slight variability has been observed due to the instrument and test cassette design themselves, or to the bead suspension used in the test well for self-calibration. The precision and repeatability of the Automarqer in application is very good, with most of the repeatuonity of the riatorias coming from the differences in the sample and its administration in the test.
Coefficients of Variation due to equipment (Automarqer, cassette) and sample
Automarger well variability:
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
0
3/19/99
(A
Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The sequence appears to be 'K990184'. The characters are written in a dark ink, and the image has a clear background.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| A)(1) Submitter's name: | Hamilton Thorne Research |
|---|---|
| Submitter's address: | 100 Cummings Center, Suite 102-C |
| Beverly, MA 01915 | |
| Submitter's telephone no.: | 978-921-2050 |
| Contact Person: | Diarmaid Douglas-Hamilton |
| Date Summary Prepared: | January 8, 1999 |
| (2) Trade or proprietary device name: | Automarqer™ |
| Common or usual name: | Differential spectrophotometer |
| Classification name: | Hematology |
| (3) Legally marketed predicate device: | IVOS sperm analysis system [Hamilton |
| Thorne Research (K920719, SE 6/29/92)] |
(4) Subject device description:
The Automarqer™ is a differential spectrophotometer for quantification of results The ? Hatomarqo. - 115 Kits * for sperm analysis. The MARQ test kits employ a unique test cassette with four wells, each containing a filter to retain the test reagents and sample suspension. The test cassette is designed to be inserted into the Automarqer for reading of results after the sample has been processed. The Automarger provides the numeric analysis of the quantity of sperm or other sperm ejaculate component being evaluated.
The Automarqer operates by measuring the well reflectivity in two wavelengths (red and green) and deriving the optical absorption in DNA-specific dyes within the wells, generated by the staining reagents used in the MARQ test kits. Each well emits a signal in the color with which it is illuminated (either red or blue dye). The first well of the test cassette provides a standard signal (using a standardized latex bead suspension), the second well provides a null signal, and the third and fourth wells provide sample signals.
The Automarqer contains an optical assembly, microprocessor and program, cassette position sensor and readout screen. Software in the microprocessor ROM directs the operations. The microprocessor detects position of the cassette as each well is inserted, stores the value of the signal from each well separately under red and green wavelength illuminations, and computes the corresponding reflectivity of the sample, using the scale defined by the difference between the first two wells (the standard signal and the null signal). In this way, the system is self-calibrating on each cassette.
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- MARQ™ Test Kits are being developed for commercialization by Embryotech Laboratories, Wilmington, MA.
1
(5) Subject device intended use:
The Automarqer™ is a differential spectrophotometer for quantification of results using Ferto;MARQTM Test Kit for sperm concentration analysis.
(6) Performance data:
Equivalent results are obtained on semen samples analyzed by both the Automarqer™ and the IVOS sperm analysis system. Only slight variability has been observed due to the instrument and test cassette design themselves, or to the bead suspension used in the test well for self-calibration. The precision and repeatability of the Automarqer in application is very good, with most of the repeatuonity of the riatorias coming from the differences in the sample and its administration in the test.
Coefficients of Variation due to equipment (Automarqer, cassette) and sample
| Automarger well variability | Sincerely yours. mana in there in there
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
C. Indications for use of the Device
Page 1 of 1
510(k) Number): Not tenown K 990184
Automarqer™ Device Name:
Indications for Use:
The Automarqer™ is a differential spectrophotometer for quantification of results using MARQTM Test Kits for sperm analysis.
(Please do not write below this line-continue on another page if needed)
美 * * * 头 美
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rita E. Madari
(Divisior. Sign Off) Division _: _!imical Laboratory Devices 510jkj Number -
Over-the-Counter Use Prescription Use_X Or (Optional Format 1-2-96) (Per 21 CFR 801.109)