(100 days)
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No
The summary describes a quality control material for immunoassay tests and does not mention any AI or ML components.
No
This device is a quality control material intended to monitor the performance of immunoassay test procedures, not to treat or cure a disease or condition.
No
This device is a quality control material used to monitor the performance of immunoassay test procedures, not to diagnose a condition in a patient.
No
The device description clearly states it is a "lyophilized quality control material," which is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "quality control material intended to monitor the performance of immunoassay test procedures that analyze clinical samples." This directly aligns with the definition of an IVD, which are used to examine specimens taken from the human body to provide information for diagnostic purposes.
- Device Description: The description confirms it's a "lyophilized assayed quality control material," which is a common type of reagent used in IVD testing.
The lack of information about image processing, AI/ML, anatomical site, patient age, user, training/test sets, performance studies, key metrics, and predicate/reference devices does not negate its classification as an IVD based on the core intended use and device description. These missing details are often related to the specifics of how a device is used or evaluated, not its fundamental classification as an IVD.
N/A
Intended Use / Indications for Use
QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized QUAEFFROE immONessayed quality control material intended to monitor the naman ocrain bacoa a immunoassay test procedures that analyze performanoo of climos. Intreaputic drugs as listed in this package insert.
Product codes
JJY
Device Description
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird with its wings spread. The image is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 9 1999
Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. 2170 Woodward Street Austin, Texas 78744-1832
Re: K992939 Trade Name: Qualitrol Immunoassay Plus Control, Levels 1, 2 and 3 Regulatory Class: I Product Code: JJY Dated: August 27, 1999 Received: August 31, 1999
Dear Mr. Sewell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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
2
INDICATIONS FOR USE STATEMENT
510(k) number (if known): K_993939
Device name:
QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3
Indications for use:
QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized QUAEFFROE immONessayed quality control material intended to monitor the naman ocrain bacoa a immunoassay test procedures that analyze performanoo of climos. Intreaputic drugs as listed in this package insert.
Pete E. Magrini
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992939
Resumption-