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.

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.

AI/ML Overview

This document is a 510(k) Summary for a Quality Control Material (QCM), not a diagnostic or therapeutic medical device. Therefore, the typical acceptance criteria and study designs associated with clinical performance (like sensitivity, specificity, reader studies, etc.) do not directly apply.

Instead, the "acceptance criteria" for a QCM like QuickCheck Liquid Chemistry Control are primarily related to demonstrating substantial equivalence to an existing predicate device based on its intended use, technological characteristics, and safety and effectiveness for its purpose. The study involves a comparative analysis of these characteristics.

Let's break down the information based on your request, adapting it to the context of a QCM 510(k) submission:

Description of Acceptance Criteria and Study

The acceptance criteria for the QuickCheck Liquid Chemistry Control device are based on demonstrating its substantial equivalence to the predicate device, "QUICKCHECK UNASSAYED CHEMISTRY CONTROL, Levels 1 and 2." This equivalence is established by comparing key technological characteristics and intended use. The study demonstrates that the new device is as safe and effective as the predicate for its intended purpose of monitoring the performance of routine chemistry analytes.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Aspects for Substantial Equivalence)	Proposed Device: QUICKCHECK LIQUID CHEMISTRY CONTROL (Assayed and Unassayed)	Predicate Device: QUICKCHECK UNASSAYED CHEMISTRY CONTROL
Intended Use	Assayed quality control serum for monitoring performance of routine chemistry test procedures.	Unassayed 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.
Conclusion of Equivalence	Information provided demonstrates substantial equivalence to predicate device.	(N/A – predicate for comparison)

Interpretation of "Performance" for a QCM: For a QCM, "performance" here refers to its suitability to serve its purpose (monitoring test procedures) and its inherent characteristics being comparable or improved in a way that doesn't raise new safety or effectiveness concerns. The key "performance" demonstrated is that the device is a quality control material with appropriate characteristics, and the differences (e.g., more analytes, more levels, assayed option) are not considered to diminish safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the traditional sense of a clinical test set. The study involves a comparative analysis of the product's specifications and characteristics against a predicate device. It's about comparing the design and composition, not analyzing a sample of clinical cases.
Data Provenance: The data comes from the specifications and characteristics of the proposed device (QuickCheck Liquid Chemistry Control) as manufactured by Consolidated Technologies, Inc. This is a prospective submission of a new product with its defined characteristics. The predicate device's characteristics are also documented specifications. The country of origin for the data is implicitly the USA, where Consolidated Technologies is located.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. Ground truth as typically defined for diagnostic device performance (e.g., disease presence/absence) is not established for a QCM.
Qualifications of Experts: Not applicable. The "ground truth" for a QCM's characteristics typically comes from internal manufacturing and quality control processes to establish its composition, stability, and target values.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "test set" in the clinical sense requiring expert adjudication. The comparison is between documented specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation devices where human reader performance is being evaluated with and without AI assistance. A Quality Control Material does not involve human interpretation or AI assistance in this manner.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This device is a physical material (control serum), not an algorithm or AI.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context refers to the defined specifications and characteristics of the Quality Control Material itself, as determined by the manufacturer through their development, manufacturing, and quality control processes. This includes the matrix, analytes present, stability, and target values or ranges (as provided to customers who request assayed product). For the purpose of substantial equivalence, the "ground truth" is that the device performs as a QCM consistent with its stated specifications and is comparable to the predicate.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. QCMs are not "trained" in the way AI algorithms are. Their "training" is analogous to the rigorous product development, formulation, and quality control that ensures consistent manufacturing and performance Lot-to-Lot.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable. As noted above, there isn't a "training set" in the AI sense. The establishment of "ground truth" (i.e., the reliable characteristics and performance of the QCM) is achieved through:
- Manufacturing processes: Controlled formulation and production to ensure specific concentrations of analytes.
- Analytical testing: In-house testing using validated methods to determine the actual values for analytes present (especially for assayed controls), stability studies, and assessment of physical properties.
- Compliance with quality systems: Adherence to Good Manufacturing Practices (GMP) and ISO standards that govern the production and testing of in vitro diagnostic products to ensure consistency and reliability.

Summary

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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.

DeviceCharacteristic	Proposed DeviceQUICKCHECK LIQUIDCHEMISTRY CONTROL	Predicate DeviceQUICKCHECK UNASSAYEDCHEMISTRY CONTROL
Intended use	Assayed quality control serum formonitoring performance of routinechemistry test procedures.	Uassayed quality control serum formonitoring performance of routinechemistry test procedures
Matrix	Human Serum	Human Serum
Form	Liquid, Frozen	Liquid, Frozen
Analytes	59 analytes of clinical significancethat may be found in serum.	43 analytes of clinical significancethat 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 viallabel.	Until expiration date noted on viallabel

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

510(k) number (if known): K

Device name:

QUICKCHECK LIQUID CHEMISTRY CONTROL (Assayed and Unassayed), Levels 1, 2 and 3

Indications for use:

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

Regulation Number and Section

§ 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.