(48 days)
K-973469
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No
The summary describes a liquid chemistry control material for monitoring clinical test procedures, with no mention of AI or ML technology in its intended use, device description, or any other section.
No.
This device is a quality control material intended to monitor the performance of clinical test procedures, not to treat or diagnose a disease.
No
The device is described as a "quality control material intended to monitor the performance of clinical test procedures" and to "monitor the performance of test procedures". It is used to check the accuracy of other diagnostic tests, not to diagnose a condition itself.
No
The device is a liquid human serum based quality control material, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "intended to monitor the performance of clinical test procedures that analyze routine chemistry analytes". This is a classic function of an in vitro diagnostic control material.
- Device Description: It describes the product as a "liquid human serum based assayed quality control material". Quality control materials used to monitor the performance of clinical tests are considered IVDs.
- Predicate Device: The predicate device listed (K-973469) is also a "CHEMISTRY CONTROL", further indicating that this type of product falls under the IVD category.
The purpose of this device is to be used in vitro (outside the body) to assess the accuracy and reliability of other diagnostic tests. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
QUICKCHECK LIQUID CHEMISTRY CONTROL is a liquid human serum based assayed quality control material intended to monitor the performance of test procedures that analyze routine chemistry analytes as listed in the package insert.
QUICKCHECK LIQUID CHEMISTRY CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze routine chemistry analytes as listed in this package insert.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
QUICKCHECK LIQUID CHEMISTRY CONTROL is designed to monitor the performance of test procedures that analyze a number of routine chemistry analytes as listed in the package insert.
This product will be offered as an assayed and unassayed control. In addition, the control is being expanded to three levels.
Mentions image processing
Not Found
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.
K-973469
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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Product Performance and Substantial Equivalency 510k Summarv
DEC 2 4 2002
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:_KOZ 37 31
- Submitter: Consolidated Technologies 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78744-1832 Phone: (512) 445-5100 (512) 445-5515 Fax:
Contact: Candice Betz Preparation date: October 31, 2002
Product name (trade & common):
- QUICKCHECK LIQUID CHEMISTRY CONTROL (Assayed and Unassayed), Proprietary: Levels 1, 2 and 3
Common: N/A
Classification name:
Class I. Product code: JJY 21 CFR 862:1660: Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
Predicate device:
QUICKCHECK UNASSAYED CHEMISTRY CONTROL, Levels 1 and 2. Consolidated Technologies, Inc. K-973469
Device description:
QUICKCHECK LIQUID CHEMISTRY CONTROL is designed to monitor the performance of test procedures that analyze a number of routine chemistry analytes as listed in the package insert.
This product will be offered as an assayed and unassayed control. In addition, the control is being expanded to three levels.
Intended use:
QUICKCHECK LIQUID CHEMISTRY CONTROL is a liquid human serum based assayed quality control material intended to monitor the performance of test procedures that analyze routine chemistry analytes as listed in the package insert.
Consolidated Technologies, Inc. 4401 Freidrich Lane Building 1, Suite 100 Austin Tx. 78744
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Product Performance and Substantial Equivalency
510(k) Summary (continued)
Labeling/Packaging:
Consolidated Technologies is a contract manufacturer. The expected values listed on the package insert for QuickCheck Liquid Chemistry Control are target ranges developed for manufacturing purposes only. These expected values are based on the product having three distinct levels. As such, CTI will manufacture, at the request of a customer, either unassayed or assayed QuickCheck Chemistry Control product.
If the customer requests an unassayed product, the expected manufacturing targets for the product will be presented for reference and a certificate of analysis will accompany the final product for completion. The certificate of analysis will list the actual values obtained for analytes present in the control (see exhibit I for example)
If the customer requests an assayed control the package insert will list the analytes present in the control and the values obtained for those analytes on various test methods and/or instrumentation. The customer determines the test methods and instrumentation. The value assignment data (assayed) are provided to the customer to develop their own package insert. See exhibit II for an example of an assay sheet.
The customer is responsible for labeling and/or package insert for the finished device.
This product is offered to the customer in the following fill sizes:
5ml fill in a 7ml amber glass vial 4ml fill in a 7 ml amber glass vial 10ml fill in a 15ml amber glass vial 10ml fill in a 15 ml plastic dropper vial
Unlabeled vials in labeled flats Labeled vials in flats Labeled vials in Labeled kits
Consolidated Technologies is also a manufacturer and will sell this product as QuickCheck Liquid Chemistry Control, Level 1, 2, and 3. The package insert will list the analytes present in the control and the values obtained for those analytes on various test methods and/or instrumentation. The assay sheet included in this 510k is an example of potential methods used to assay the product. See Exhibit II, III, IV and V, for all labeling and package insert and example assay sheet.
QuickCheck Liquid Chemistry Control is sold in the following configurations:
5ml in a 7ml labeled vials 10ml in a 15ml labeled vials The above kitted are 5 of each level to equal 15 vials of the same level Package Insert
Consolidated Technologies, Inc. 4401 Freidrich Lane Building 1. Suite 100 Austin Tx. 78744
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Product Performance and Substantial Equivalency
510(k) Summary (continued)
Comparative analysis:
The table below provides a summary of the technological characteristics between QUICKCHECK LIQUID CHEMISTRY CONTROL and the predicate device.
| Device
Characteristic | Proposed Device
QUICKCHECK LIQUID
CHEMISTRY CONTROL | Predicate Device
QUICKCHECK UNASSAYED
CHEMISTRY CONTROL |
|--------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended use | Assayed quality control serum for
monitoring performance of routine
chemistry test procedures. | Uassayed quality control serum for
monitoring performance of routine
chemistry test procedures |
| Matrix | Human Serum | Human Serum |
| Form | Liquid, Frozen | Liquid, Frozen |
| Analytes | 59 analytes of clinical significance
that may be found in serum. | 43 analytes of clinical significance
that may be found in serum |
| Levels | Three (3) levels | Two (2) levels |
| Preservatives | Ciprofloxacin | Ciprofloxacin |
| Storage | -20°C | -20°C |
| Stability | Until expiration date noted on vial
label. | Until expiration date noted on vial
label |
Conclusions:
The information provided in the pre-market notification demonstrates that QUICKCHECK LIQUID CHEMISTRY CONTROL (Assayed and Unassayed) is substantially equivalent to the predicate device, for which there is FDA clearance. This equivalence was demonstrated through comparison of intended uses and physical properties to a commercially available The information supplied in the pre-market notification provides reasonable device. assurance that QUICKCHECK LIQUID CHEMISTRY CONTROL is safe and effective for the stated intended use.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. Inside the circle is a stylized design featuring four wavy lines that resemble a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEC 24 2002
ood and Drug Administrati 2098 Gaither Road Rockville MD 20850
Ms. Candice Bentz Quality Manager Consolidated Technologies, Inc 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78744
Re: K023731
Trade/Device Name: QuickCheck Liquid Chemistry Control (Assayed and Unassayed). Levels 1. 2. and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 31, 2002 Received: November 6, 2002
Dear Ms. Bentz:
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. Iisting 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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Page 2
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). 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS OF USE STATEMENT
© 2373
510(k) number (if known): K
Device name:
QUICKCHECK LIQUID CHEMISTRY CONTROL (Assayed and Unassayed), Levels 1, 2 and 3
Indications for use:
QUICKCHECK LIQUID CHEMISTRY CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze routine chemistry analytes as listed in this package insert.
Sea
ean
Division Sign-Off)
Clinical Laboratory Device.
510(K) Nr. K033731
.
prescription use
Consolidated Technologies, Inc. 4401 Freidrich Lane Building 1, Suite 100 Austin Tx. 78744