LIGAND PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in this package insert.

Device Description

LIGAND PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix. The product contains <0.1% sodium azide. This product will be offered as an assayed or unassayed three level control.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "LIGAND PLUS CONTROL." This document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, "IMMUNOASSAY PLUS CONTROL."

However, it's important to note that the document does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the way that would typically be presented for image-based diagnostic AI, for example. Instead, it focuses on demonstrating substantial equivalence by comparing technical characteristics, intended use, and manufacturing processes to a predicate device.

Therefore, many of the requested sections (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission for a quality control material.

I will fill in the table and address the other points based on the available information.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for a medical device in a 510(k) submission, especially for a quality control material, primarily revolves around demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as the predicate. The performance is assessed by comparing its characteristics and intended use.

Table of Acceptance Criteria and Reported Device Performance (as inferred from substantial equivalence claims):

Acceptance Criterion (Inferred from Substantial Equivalence Basis)	Reported Device Performance (LIGAND PLUS CONTROL)
Intended Use Equivalence: Monitor performance of routine chemistry test procedures.	Assayed or unassayed quality control for monitoring performance of routine chemistry test procedures. (Matches Predicate)
Matrix Equivalence: Processed Human Serum.	Processed Human Serum. (Matches Predicate)
Form Equivalence: Lyophilized.	Lyophilized. (Matches Predicate)
Number of Levels Equivalence: Three (3) Levels.	Three (3) Levels. (Matches Predicate)
Storage Equivalence: 2 °C to 8 °C.	2 °C to 8 °C. (Matches Predicate)
Stability Equivalence: Until expiration date noted on vial label.	Until expiration date noted on vial label. (Matches Predicate)
Analyte Content (Functional Equivalence): Capable of monitoring clinically significant analytes.	Contains 55 analytes of clinical significance. (Comparable to Predicate's 59 analytes, implying similar function)

Note on "Acceptance Criteria" for this device: For a quality control material in a 510(k) submission focused on substantial equivalence to a predicate, the "acceptance criteria" are implicitly met if the device demonstrates comparable characteristics and performance to the predicate device. The submission does not provide explicit numerical performance targets (e.g., specific accuracy, precision, or bias limits) for the LIGAND PLUS CONTROL itself in the context of demonstrating its own effectiveness, but rather demonstrates its equivalence to a device already deemed safe and effective. The customer/end-user would then establish their own analyte assay criteria using this control.

Study Details

The provided text describes a 510(k) submission for substantial equivalence. This type of submission relies on comparisons to a predicate device rather than a comprehensive de novo performance study with the characteristics typically seen for diagnostic algorithms.

Here's an assessment based on the available information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The submission focuses on comparing the "Device Characteristic" features (Intended use, Matrix, Form, Analytes, Levels, Storage, Stability) of the proposed device against the predicate. This isn't a "test set" in the sense of a dataset to evaluate an algorithm's classification performance. Instead, it's a comparison of product specifications.
- Data Provenance: Not specified. The data provided are product specifications and manufacturing targets, not clinical study results from specific countries.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. "Ground truth" in the context of expert consensus for a test set (like for an imaging algorithm) is not relevant for this type of device (quality control material) or submission type (substantial equivalence via characteristic comparison). The "truth" here is the established specifications and performance of the predicate device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None. There's no "adjudication" in the sense of reconciling expert opinions on diagnoses. The comparison is based on objective product characteristics and intended use.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a quality control material, not an AI diagnostic algorithm or an assist tool for human readers. Therefore, an MRMC study is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a biochemical control, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Product Specifications and Regulatory Precedent: The "ground truth" for this submission is effectively the established and accepted characteristics and performance of the predicate device, IMMUNOASSAY PLUS CONTROL, which has already received FDA clearance (K020237). The goal is to demonstrate the new device's equivalence to this established "truth." For the LIGAND PLUS CONTROL itself, "expected values" are manufacturing targets, and actual values are determined by the customer for assayed products.
The sample size for the training set:
- Not applicable / Not provided. There is no "training set" as this is not an AI/ML algorithm.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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JAN 1 6 2004

Product Performance and Substantial Equivalency 510k Summary

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: _ Ko 333 44

Submitter: Consolidated Technologies 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78744-1832 Phone: (512) 445-5100 Fax:
October 2nd, 2003 Contact: Candice Betz Preparation date:

Product name (trade & common):

Proprietary: LIGAND PLUS CONTROL Level 1 - 3

Also sold as:

Consolidated Technologies will also sell this product as an unassayed OEM product, as well as an assayed OEM product. Individual customers will establish analyte assay criteria from the list of analytes provided. Consolidated Technologies will manufacture the product to the customer specifications (refer to Exhibit I). Customer specifications and Labeling criteria of OEM customers are maintained in the 510k file. Any regulatory compliance for labeling is the OEM Customers' responsibility.

Classification name:

Product code: DIF

CFR section: 21CFR 862.3280 Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

Predicate device:

IMMUNOASSAY PLUS CONTROL Levels 1, 2 and 3 Consolidated Technologies, notification number K020237.

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Product Performance and Substantial Equivalency

510(k) Summary (continued)

Device description:

LIGAND PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert.

Human origin components are added to a human serum based matrix. The product contains <0.1% sodium azide.

This product will be offered as an assayed or unassayed three level control.

Intended use:

LIGAND PLUS CONTROL is a fyophilized human serum based assayed quality control material intended to monitor the performance of serum immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert.

Comparative analysis:

The table below provides a summary of the technological characteristics between LIGAND PLUS CONTROL and the predicate device.

DeviceCharacteristic	Proposed DeviceLIGAND PLUS CONTROL	Predicate DeviceIMMUNOASSAY PLUSCONTROL
Intended use	Assayed or unassayed qualitycontrol for monitoringperformance of routinechemistry test procedures.	Assayed or unassayed qualitycontrol for monitoringperformance of routinechemistry test procedures.
Matrix	Processed Human Serum	Processed Human Serum
Form	Lyophilized	Lyophilized
Analytes	55 analytes of clinicalsignificance	59 analytes of clinicalsignificance
Levels	Three (3) Levels	Three (3) levels
Storage	2 °C to 8 °C	2 °C to 8 °C
Stability	Until expiration date noted onvial label.	Until expiration date noted onvial label.

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Product Performance and Substantial Equivalency

510(k) Summary (continued)

Labeling/Packaging:

Consolidated Technologies is a manufacturer and a contract manufacturer of OEM products. The following will describe the potential ways that LIGAND PLUS CONTROL could be labeled.

Consolidated Technologies is a manufacture and will sell this product as LIGAND PLUS 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 assay sheet included in this 510k is an example of potential methods used to assay the product. See Exhibit III thru Exhibit VI, for all labeling and package insert and example assay sheet.

LIGAND PLUS CONTROL Levels 1 - 3 will be packaged as follows:

5 X 5.0 mL Levels 1-3 Package Insert/assay sheet

Consolidated Technologies is a contract manufacturer. The expected values listed on the Product Requirement Document (product specification) for LIGAND PLUS CONTROL are target ranges developed for manufacturing purposes only (see Exhibit I). 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 LIGAND PLUS 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 II for example).

If the customer requests an assayed control, the customer will determine the test methods, specific analytes (from submitted analyte list), and instrumentation. The value assignment data (assayed) are provided to the customer to develop their own package insert. Consolidated Technologies will provide a certificate of analysis that lists the actual values obtained for the analytes specified by the customer. See exhibit I for C of A.

The customer is responsible for labeling and/or package insert for finished device.

OEM product is offered to customers in the following configurations:

5ml fill in a 7ml amber glass vial Customer labeled vials in flats

Unlabeled vials in labeled flats Customer labeled vials in labeled kits

Consolidated Technologies, Inc. 4401 Freidrich Lane Building 1, Suite 100 Austin Tx. 78744

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Conclusions:

The information provided in the pre-market notification demonstrates that LIGAND PLUS CONTROL 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 device. The information supplied in the pre-market notification provides reasonable assurance that LIGAND PLUS CONTROL is safe and effective for the stated intended use.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 6 2004

Ms. Candice Betz Quality Manager Consolidated Technologies, Inc. 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78744

Re: K033344

Trade/Device Name: Ligand Plus Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: December 17, 2003 Received: December 18, 2003

Dear Ms. Betz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to 112) 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetter For (110) and the device, subject to the general controls provisions of the Act. The r ou may, atcrerere, mains of the Act include requirements for annual registration, listing of general voltable proficituring 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 If your device is elasbined (sover of ols. Existing major regulations affecting your device can may oc subject to saon ademically in the relations (CFR), Parts 800 to 895. In addition, FDA be found in Title 21, Occureements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Ticase oc advised that I Drivice complies with other requirements of the Act that I DA has made a covernmalations administered by other Federal agencies. You must of any I cacal statutes and regulations, including, but not limited to: registration and listing (21 comply with and 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). 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jeann M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology 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_0333444

Device name:

LIGAND PLUS CONTROL

Indications for use:

Carol C. Benenfeld/Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033344

✓

Over-The-Counter 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.