← Product Code [POV](/productcode/POV) · K990184 # AUTOMARQER (K990184) _Hamilton Thorne Research · POV · Mar 19, 1999 · Hematology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K990184 ## Device Facts - **Applicant:** Hamilton Thorne Research - **Product Code:** [POV](/productcode/POV.md) - **Decision Date:** Mar 19, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5220 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The Automarqer™ is a differential spectrophotometer for quantification of results using Ferto;MARQTM Test Kit for sperm concentration analysis. ## Device Story Automarqer™ is a differential spectrophotometer for sperm concentration analysis. Input: test cassette containing four wells (standard, null, and two sample wells) processed with MARQ test kits. Operation: device measures well reflectivity at red and green wavelengths; microprocessor calculates optical absorption of DNA-specific dyes; system performs self-calibration using standard and null wells on each cassette. Output: numeric analysis of sperm quantity. Used in clinical settings; operated by laboratory personnel. Healthcare providers use numeric output to assess sperm concentration. Benefits: provides automated, reproducible quantification of sperm concentration compared to manual methods. ## Clinical Evidence Bench testing and clinical comparison performed. Precision/repeatability testing showed equipment/cassette variability <1.1% and sample variability 2.4%. Clinical study of 35 samples compared Automarqer to IVOS system, demonstrating high correlation (r=0.997). Reproducibility confirmed across three operators using 11 samples. ## Technological Characteristics Differential spectrophotometer; measures reflectivity at red and green wavelengths. Includes optical assembly, microprocessor, cassette position sensor, and readout screen. Self-calibrating via standardized latex bead suspension in test cassette. Software-controlled processing. ## Regulatory 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. ## Special Controls *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.” ## Predicate Devices - IVOS sperm analysis system ([K920719](/device/K920719.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. - * 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 | < 0.15% | |------------------------------|---------| | Cassette well variability | 1.1% | | Sample well variability | 2.4% | | simulated sample variability | 20% | | actual sample variability | 16% | 35 clinical samples obtained for analysis of sperm concentration by both the Automarger and the IVOS show high degree of correlation, r = 0.997, and samples run by three different operators on 11 samples also showed reproducibility. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with flowing lines suggesting movement or energy. 10903 New Hampshire Avenue Silver Spring, MD 20993 Hamilton Thorne Research c/o Diarmaid Douglas-Hamilton Vice President, Research and Development 100 Cummings Center, Suite 102-C Beverly, MA. 01915 DEC 2 1 2012 Re: k990184 Trade/Device Name: AutoMARQER™ Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: January 8, 1999 Received: January 20, 1999 Dear Dr. Diarmaid Douglas-Hamilton: This letter corrects our substantially equivalent letter of March 19, 1999. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of {3}------------------------------------------------ ## Page 2 - Diarmaid Douglas-Hamilton medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. > 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) --- **Source:** [https://fda-staging.innolitics.com/device/K990184](https://fda-staging.innolitics.com/device/K990184) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com