(36 days)
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No
The summary describes a quality control material for laboratory testing, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an assayed quality control material to monitor the precision of laboratory testing procedures, not for direct therapeutic intervention for a patient.
No
This device is described as an "assayed quality control material" used to monitor the precision of laboratory testing procedures, not to diagnose a condition directly in a patient.
No
The device is described as a "quality control material" for laboratory testing procedures. This indicates a physical substance or material used for calibration and quality assurance, not a software application.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures for Hemoglobin A1c and methods listed in this package insert." This indicates the device is used in vitro (outside the body) to analyze a sample (presumably blood, given the mention of Hemoglobin A1c) to assess the performance of a diagnostic test.
- Device Type: It is described as an "assayed quality control material." Quality control materials are a common type of IVD used to ensure the accuracy and reliability of diagnostic tests performed in a laboratory setting.
- Intended User/Care Setting: The intended user is "laboratory testing procedures," which aligns with the use of IVDs in clinical or analytical laboratories.
The lack of information on device description, image processing, AI/ML, performance studies, etc., is not unusual for a quality control material, as its primary function is to provide a known value for comparison, not to perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for Hemoglobin A1c and methods listed in this package insert.
Product codes
JJX
Device Description
MAS® Diabetes Control Dade® Diabetes Control Liquid Assayed Diabetes Control Level 1 and 2
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, composed of three curved lines. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 5 2004
Ms. Mary Thorsness Compliance Specialist Medical Analysis Systems, Inc. 5300 Adolfo Road Camarillo, CA 93012
Re: K042717
Trade/Device Name: MAS® Diabetes Control Dade® Diabetes Control Liquid Assayed Diabetes Control Level 1 and 2 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 29, 2004 Received: October 4, 2004
Dear Ms. Thorsness:
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Liquid Assayed Diabetes Control
Medical Analysis Systems Inc. 510(k) Notification . September 29, 2004
INDICATIONS FOR USE FORM
510(k) Number (if known): _ K 042
MAS® Diabetes Control Device Name: Dade ® Diabetes Control Liquid Assayed Diabetes Control Level 1 and 2
Indications for Use:
Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for Hemoglobin A1c and methods listed in this package insert.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benam
Division Sign-Off
..............................................................................................................................................................................
Office of In Vitro Diagnostla Device Evaluation and Safety
510(k) K042717
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