(50 days)
No
The document describes an in vitro diagnostic control product used for quality control of automated instrumentation and reagents. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is turbidimetry, a standard laboratory method.
No
The device is described as an "in vitro diagnostic product" intended for "quality control" of test results, not for treating or diagnosing patients.
No
The device is described as an "in vitro diagnostic product" intended for "quality control" and "monitoring the quality control of results obtained with ... reagents." It is not directly used to diagnose a patient's condition.
No
The device is an in vitro diagnostic product described as a "control" which is a physical substance used to monitor the quality of results from other reagents and automated instrumentation. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents."
The "Device Description" section also begins by stating: "The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents."
These statements clearly identify the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents. When the combined control, which ADO prob, qualiten Ord problem of antistreptolysin-O, C-reactive protein and rheumatoid factor, commits a known asserver raias our suantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.
Product codes
JJT
Device Description
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents. When the combined control, which ADO prob, qualiten Ord problem of antistreptolysin-O, C-reactive protein and rheumatoid factor, commits a known asserver raias our suantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In a comparative performance study on a COBAS Mira, the new quantex ASO-CRP-RF control II exhibited excellent with-in run precision in comparison to the precise control. control 11 Exmoned excellent with in run %CV for the new control was 2.7% (ASO), 1.6% (CRP) and 1.1 (RF) as compared to with-in run %CV for the predicate control of 4.8% (ASO plus), 3.5% (CRP) and 1.7% (RF).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The new control was 2.7% (ASO), 1.6% (CRP) and 1.1 (RF) as compared to with-in run %CV for the predicate control of 4.8% (ASO plus), 3.5% (CRP) and 1.7% (RF).
Predicate Device(s)
quantex ASO-CRP-RF control K971777
Reference Device(s)
Not Found
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.
0
1984437
FEB 2 1999
Section 3 quantex ASO-CRP-RF control II - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4464 Fax:
Contact Person:
Carol Marble Phone: 781-861-4467 / Fax: 781-861-4464
Summary Prepared:
December 11, 1998
Name of the device:
quantex ASO-CRP-RF control II
Classification name(s):
Quality Control Material (Assayed and Unassayed) Class I 862.1660
Identification of predicate devices:
quantex ASO-CRP-RF control K971777
Description of the device/intended use(s):
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents. When the combined control, which ADO prob, qualiten Ord problem of antistreptolysin-O, C-reactive protein and rheumatoid factor, commits a known asserver raias our suantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
The new quantex ASO-CRP-RF control II is substantially equivalent in performance, intended use and safety and effectiveness to the predicate control: quantex ASO-CRP-RF control.
Summary of Performance Data:
In a comparative performance study on a COBAS Mira, the new quantex ASO-CRP-RF control II exhibited excellent with-in run precision in comparison to the precise control. control 11 Exmoned excellent with in run %CV for the new control was 2.7% (ASO), 1.6% (CRP) and 1.1 (RF) as compared to with-in run %CV for the predicate control of 4.8% (ASO plus), 3.5% (CRP) and 1.7% (RF).
Section 3
quantex ASO-CRP-RF control II 510(k)
Page 1 of 1
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Image /page/1/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB | 2 1999
Carol Marble Regulatory Affairs Manager INSTRUMENTATION LABORATORY COMPANY 113 Hartwell Avenue Lexington, MA 02421
Re: K984437 Trade Name: quantex ASO-CRP-RF control II Requlatory Class: I Product Code: JJT December 11, 1998 Dated: December 14, 1998 Received:
Dear Ms. Marble:
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 aqainst 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 Quality 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 In addition, FDA may publish further regulatory action. 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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Page 2
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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
3
Indications for Use Statement
510(k) Number (if known): K984437
Device Name: quantex ASO-CRP-RF control II
Indications for Use:
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.
Peter E. Machin
(Division Sign-Off)
Division of Clinical Laboratory Devices
(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 801.019)
OR Over-The-Counter Use _