(78 days)
The Aalto Scientific Micro Hematocrit Control are human blood based solutions intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for hematocrit.
The Aalto Scientific Micro Hematocrit Controls are prepared using human blood and chemicals, including less than 0.1% sodium azide as preservative. The Aalto Scientific Micro Hematocrit Controls are for in vitro diagnostic use only. The human components used in the manufacture of the product have been tested and found to be non reactive by FDA approved methods for HIV 1/2, HbsAg HCV and HTLV 1/2.
This document is a 510(k) summary for the Aalto MicroHematocrit Control, a device used to monitor the precision of laboratory testing procedures for hematocrit. It claims substantial equivalence to STI Hematachek Separation Technology. This submission does not contain a study with acceptance criteria for device performance.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on describing the device, its intended use, and its technological characteristics compared to a predicate device, as required for a 510(k) submission seeking substantial equivalence, rather than presenting a performance study with detailed acceptance criteria and results.
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MAY 1 4 2002
PAGE 6
510K SUMMARY
Submitted by: Aalto Scientific, Ltd. 1959 Kellogg Avenue Carlsbad, CA 92008 Tel: 760-431-7922 Fax: 760-431-6942
Contact Person: Kenneth Gauthier
Date of Summary Preparation: February 19, 2002
Device: (Trade and Common Name)
Aalto MicroHematocrit Control
Classification Name:
CFR 864.8625, Control, Hematocrit
Device to Which Substantial Equivalence is Claimed:
STI Hematachek Separation Technology, Inc. 1096 Rainier Drive Altamonte Springs, FLA K964452
Statement of Intended Use:
The Aalto Scientific Micro Hematocrit Control are human blood based solutions intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for hematocrit.
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PAGE 7
510(k) SUMMARY - CONTINUED
Description of the Device:
The Aalto Scientific Micro Hematocrit Controls are prepared using human blood and chemicals, including less than 0.1% sodium azide as preservative. The Aalto Scientific Micro Hematocrit Controls are for in vitro The human components used in the diagnostic use only. manufacture of the product have been tested and found to be non reactive by FDA approved methods for HIV 1/2, HbsAg HCV and HTLV 1/2.
Statement of Technological Characteristics Compared to Equivalent Device:
Intended Use: Both devices are intended to monitor the precision of methods used to measure whole blood spun hematocrit.
Form: Both devices are liquids
Matrix: Both devices use stabilized Red Blood Cells as the matrix.
Storage: Both devices can be stored and used at controlled room temperature.
Stability: Both devices can be stored for 2 years at controlled room temperature, unopened.
Symph Patt
Kenneth Gauthier Quality Control Manager
02.21.02
Date
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo of the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 4 2002
Mr. Kenneth Gauthier Ouality Control Manager Aalto Scientific, Limited 1959 Kellogg Avenue Carlsbad. California 92008
K020618 Re:
Trade/Device Name: Aalto Micro Hematocrit Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Control, Hematocrit Regulatory Class: II Product Code: GLK Dated: April 12, 2002 Received: April 29, 2002
Dear Mr. Gauthier:
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 either class II (Special Controls) or class III (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and in you word 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 additionally 60911-01-11-2011 on the promotion and advertising of your device, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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Page __ of_
510(k) Number (if known): Ko 20618
Aalto Scientific Ltd. Device Name: _
Micro Hematocrit Control
Indications For Use:
The Aalto Scientific Micro Hematocrit Controls are human blood based solutions intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for hematocrit
(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__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Josephine Bautista
nical Laboratory
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.