(140 days)
Not Found
MAS Diabetes Control
No
The summary describes a laboratory quality control material, not a device that processes data or images using AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections explicitly state "Not Found".
No
This device is a quality control material for laboratory procedures, not a device used to treat or diagnose patients.
No.
This device is a quality control material used for laboratory procedures that quantitate HbA1c, not a diagnostic device itself. Its purpose is to ensure the accuracy of the diagnostic tests.
No
The device description clearly states it is a frozen liquid control material supplied in bottles, which is a physical product, not software.
Yes, based on the provided information, the Quantimetrix Dropper Alc Diabetes Control is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quality control of laboratory procedures used to quantitate HbA1c." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: The description details a product used in a laboratory setting ("prepared in a whole blood matrix") and designed to be used with laboratory procedures.
- Predicate Device: The mention of a predicate device (MAS Diabetes Control) which is also a control material for diabetes testing further supports its classification as an IVD. Control materials are a common type of IVD used to ensure the accuracy and reliability of diagnostic tests.
Therefore, all the key indicators point to this device being an IVD.
N/A
Intended Use / Indications for Use
The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.
Product codes
JJX
Device Description
Dropper A1c Controls are supplied in two levels, 4 bottles total, 2 x 2 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a whole blood matrix fortified to target levels with reagent grade chemicals added to achieve the two levels. Preservatives have been added to inhibit microbial growth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory procedures
Description of the training set, sample size, data source, and annotation protocol
Assayed values are determined from in-house data.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
MAS Diabetes Control
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/0 description: The image features the logo of Quantimetrix Corporation on the lower left side. The logo consists of the letters 'QC' in a stylized font, with the full name of the corporation written below. In the upper right corner, there is a handwritten alphanumeric code 'K103744'. The background is a combination of white and black, with a curved line separating the two colors.
510K Summary
Dec. 14, 2010 Prepared:
Submitted by: Quantimetrix Corporation
Establishment Address:
Quantimetrix Corporation 2005 Manhattan Beach Boulevard Redondo Beach CA 90278 Phone: 310/536-0006 FAX: 310/536-9977
Establishment Registration Number: 2020715 Contact Person: Kalyna Snylyk, Director of Ouality Assurance & Regulatory Affairs Proprietary Name: Dropper A1c Diabetes Control Common Name: Hemoglobin A1c Control Classification Name: Single (Specified) Analyte Quality Control Material (Assayed and Unassayed), (21 CFR 862.1660) Product Code: JJX
Substantial Equivalence:
The Quantimetrix Dropper Alc Diabetes Control is supplied as a frozen liquid in two levels and consists of a human whole blood matrix containing preservatives to which reagent grade chemicals were added to chemically react with the hemoglobin to achieve the two levels.
The Quantimetrix controls are substantially equivalent to other such controls in general use, such as the MAS Diabetes Control, sold by Microgenics Corporation Inc., which is supplied liquid in two levels as a whole blood matrix with pure chemicals added by the manufacturer.
Assayed values are determined from in-house data.
www.4ac.co 800,624.8380 | 310,536.0006 tel 800.624.18341310.536.9977 fax 2005 Manhattan Beach Boulevard, Redondo Beach, CA 90278 USA
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Image /page/1/Picture/0 description: The image shows the logo for Quantimetrix Corporation. The logo consists of the letters 'QC' stacked on top of each other, with the word 'Quantimetrix' written below the letters. The word 'Corporation' is written below 'Quantimetrix'. The logo is in black and white and is placed on a white background with a black curved line at the top.
Description:
Dropper A1c Controls are supplied in two levels, 4 bottles total, 2 x 2 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a whole blood matrix fortified to target levels with reagent grade chemicals added to achieve the two levels. Preservatives have been added to inhibit microbial growth.
Intended Use:
The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.
Technological Characteristics Compared to Predicate Devices:
The Quantimetrix control product employs a similar matrix and constituent formulation to the equivalent predicate device listed above: whole blood matrix fortified with reagent grade chemicals as well as preservatives. The Quantimetrix Control also has similar storage and stability requirements as the equivalent devices.
Image /page/1/Picture/7 description: This image contains contact information for a company. The website is www.4qc.com. The phone numbers are 800.624.8380 and 310.536.0006, and the fax numbers are 800.624.1834 and 310.536.9977. The address is 2005 Manhattan Beach Boulevard, Redondo Beach, CA 90278 USA.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name encircling the image and a stylized symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 1 2 2011
Quantimetrix Corporation c/o Kalyna Snylyk Director, Quality Assurance/Regulatory Affairs 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278
Re: K103744
Trade Name: Dropper A1c Diabetes Control Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: December 17, 2010 Received: March 7, 2011
Dear Ms. Snylyk:
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); medical device reporting (reporting of 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).
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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 (21 CFR Parls 801 and 5450. Also, please note the regulation entitled, "Misoranding 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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Enclosure
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Indications for Use Form.
510(k) Number (if known):
Dropper™ A1c Diabetes Control Device Name:
Indications for Use:
The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-CounterUse _ AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103744
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