Liquichek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Description

Liquichek Tumor Marker Control is prepared from human source material with added constituents of human and animal origin, chemicals, stabilizers and preservatives. The control is provided in liquid form for convenience.

AI/ML Overview

This document is a 510(k) Summary for a quality control material, not a medical device that would typically undergo a study with acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" here refer to the stability claims of the control material, and the "study" is the stability testing performed.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

For a quality control material, "acceptance criteria" are typically related to its stability and ability to maintain its assigned values over specific storage conditions and timeframes. The performance is the duration for which these conditions are met.

Characteristic	Acceptance Criteria (Claimed Stability)	Reported Device Performance (Established Stability)
Thawed and Opened Stability	IGF-1: 15 days at 2 to 8°CCA 125: 10 days at 2 to 8°CAll other analytes: 30 days at 2 to 8°C	IGF-1: 15 days at 2 to 8°CCA 125: 10 days at 2 to 8°CAll other analytes: 30 days at 2 to 8°C
Thawed and Unopened Stability	IGF-I, PAP: 35 days at 2 to 8°CFree PSA: 30 days at 2 to 8°CCA 125: 14 days at 2 to 8°CAll other analytes: 60 days at 2 to 8°C	IGF-I, PAP: 35 days at 2 to 8°CFree PSA: 30 days at 2 to 8°CCA 125: 14 days at 2 to 8°CAll other analytes: 60 days at 2 to 8°C
Frozen Aliquot Stability	All analytes: 30 days at -20°C to -70°C	All analytes: 30 days at -20°C to -70°C
Shelf Life Stability	28 months at -20 to -70°C	28 months at -20 to -70°C

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state a "sample size for the test set" in the context of clinical performance or diagnostic accuracy. Instead, it refers to stability studies. The details for these studies are:

Sample Size: Not specified in terms of number of runs or batches, but implies "a representative sampling of this lot of product" was used for value assignment and stability testing.
Data Provenance: The studies were performed internally by Bio-Rad Laboratories and/or "independent laboratories." The country of origin is not specified, but Bio-Rad Laboratories is based in California, USA.
Retrospective or Prospective: These would be prospective studies, as they involve testing the product over time under various storage conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a quality control material and not a diagnostic device requiring expert interpretation of results to establish "ground truth" for a test set. The "ground truth" for this device relates to the assigned quantitative values of the analytes within the control material, which are established through a process called "Value Assignment."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for a quality control material. Value assignment and stability testing are typically performed through replicate analyses and statistical methods, not through expert adjudication.

5. 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

This is not applicable. The device is a quality control material, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device itself is a material, not an algorithm. Its "performance" is its stability and the reproducibility of its assigned values when tested by laboratory instruments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a quality control material, the "ground truth" refers to the established, target values of the analytes within the control. This is established through:

Value Assignment: "The mean values and corresponding ±3SD ranges in the Assignment of Values Data Charts were derived from replicate analyses and are specific for this lot of product. Data from Unity™ Interlaboratory Program are included in the determination of some ranges." This indicates a process involving extensive laboratory testing and potentially interlaboratory comparisons to determine accurate and precise target values.

8. The sample size for the training set

This is not applicable. This device is a quality control material, not an algorithm that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable, as there is no "training set" for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 11, 2017

BIO-RAD LABORATORIES SUZANNE PARSONS REGULATORY AFFAIRS MANAGER 9500 JERONIMO ROAD IRVINE CA 92618-2017

Re: K163015

Trade/Device Name: Liquichek Tumor Marker Control-level 1; Liquichek Tumor Marker Control-level 2; Liquichek Tumor Marker Control-level 3; Liquichek Tumor Marker Control- Trilevel Minipak Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJY Dated: October 26, 2016 Received: October 28, 2016

Dear Ms. Parsons:

This letter corrects our substantially equivalent letter of January 10, 2017.

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kelly Oliner -S

For

Leonthena Carrington, MBA, MS, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163015

Device Name Liquichek Tumor Marker Control

Indications for Use (Describe)

Liquichek Tumor Marker Control is intended for use as an assayed quality control serum to moni tor the precision of laboratory testing procedures for the analytes listed in this package insert.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv

Liquichek Tumor Marker Control

1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:

Contact Person

Suzanne Parsons RA/QA Supervisor Telephone: (949) 598-1467

Date of Summary Preparation

January 3rd 2017

2.0 Device Identification

Product Trade Name: Common Name: Classifications: Product Code: Requlation Number:

Liquichek Tumor Marker Control Multi-Analyte Controls, All Kinds (Assayed) Class I, Reserved JJY 21 CFR 862.1660

3.0 Device to Which Substantial Equivalence is Claimed

Liquichek Tumor Marker Control Bio-Rad Laboratories Predicate 510(k) Number: K071675

4.0 Description of Device

The human source material used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBSAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

5.0 Value Assignment

The mean values and corresponding ±3SD ranges in the Assignment of Values Data Charts were derived from replicate analyses and are specific for this lot of product. Data from Unity™ Interlaboratory Program are included in the determination of some ranges.

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The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.

6.0 Intended Use

Liquichek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

7.0 Comparison of the new device with the Predicate Device

Liquichek Tumor Marker Control claims substantial equivalence to Liquichek Tumor Marker Control (K071675). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

Characteristics	Liquichek Tumor Marker Control(New Device)	Liquichek Tumor Marker Control(Predicate Device, K071675)
Similarities
Intended Use	Liquichek Tumor Marker Control is intended foruse as an assayed quality control serum tomonitor the precision of laboratory testingprocedures for the analytes listed in this packageinsert.	Liquichek Tumor Marker Control is intended foruse as an assayed quality control serum tomonitor the precision of laboratory testingprocedures for the analytes listed in this packageinsert.
Matrix	Human source material and constituents ofanimal origin	Human source material and constituents ofanimal origin
Form	Liquid	Liquid
Storage unopened(Shelf life)	-20°C to -70°C until expiration date	-20°C to -70°C until expiration date
Thawed UnopenedStability	All analytes: 60 days at 2 to 8°C	All analytes: 60 days at 2 to 8°C
	Except IGF-I, PAP: 35 days at 2 to 8°C	Except IGF-I, PAP: 35 days at 2 to 8°C
	Free PSA: 30 days at 2 to 8°C	Free PSA: 30 days at 2 to 8°C
	CA 125: 14 days at 2 to 8°C	CA 125: 14 days at 2 to 8°C
Thawed OpenedStability	All analytes: 30 days at 2 to 8°C	All analytes: 30 days at 2 to 8°C
	Except IGF-1: 15 days at 2 to 8°C	Except IGF-1: 15 days at 2 to 8°C
	CA 125: 10 days at 2 to 8°C	CA 125: 10 days at 2 to 8°C
Fill Volume	Level 1, 2 and 3 – 6 x 2 mL	Level 1, 2 and 3 – 6 x 2 mL
	Trilevel MiniPak - 3 x 2 mL	Trilevel MiniPak - 3 x 2 mL
Differences
Frozen aliquot	30 days at -20 to -70 °C	No Claim

Table 1. Similarities and Differences between new and predicate device.

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Analytes	Contains:	Contains:
	Alpha Fetoprotein (AFP) Beta-2-Microglobulin (B2-M) CA 15-3 CA 19-9 CA 27.29 CA 125 Carcinoembryonic Antigen (CEA) Ferritin Her-2/neu Human Chorionic Gonadotropin (hCG)/(β-hCG, Total hCG, Intact hCG) Human Epididymis Protein 4 (HE4) Insulin-like Growth Factor-I (IGF-1) Prostatic Acid Phosphatase (PAP) Prolactin Prostate Specific Antigen, Total (Total PSA) Prostate Specific Antigen, Free (Free PSA) Thyroglobulin (Tg)	Alpha Fetoprotein (AFP) Beta-2-Microglobulin (B2-M) CA 15-3 CA 19-9 CA 27.29 CA 125 Carcinoembryonic Antigen (CEA) Ferritin Human Chorionic Gonadotropin (hCG)/(β-hCG, Total hCG, Intact hCG) Insulin-like Growth Factor-I (IGF-1) Prostatic Acid Phosphatase (PAP) Prolactin Prostate Specific Antigen, Total (Total PSA) Prostate Specific Antigen, Free (Free PSA) Thyroglobulin (Tg) Does not Contain: Her-2/neu Human Epididymis Protein 4 (HE4)

8.0 Statement of Supporting Data

Real time stability studies were performed to establish Thawed and Opened. Thawed and unopened and Frozen Aliquot stability claims. Accelerated stability studies were performed for establishing the stability. The stabilities for Liquichek Tumor Marker Control are as follows

Thawed and Opened Stability	IGF-1: 15 days at 2 to 8°CCA 125: 10 days at 2 to 8°CAll other analytes: 30 days at 2 to 8°C
Thawed and Unopened Stability	IGF-I, PAP: 35 days at 2 to 8°CFree PSA: 30 days at 2 to 8°CCA 125: 14 days at 2 to 8°CAll other analytes: 60 days at 2 to 8°C
Frozen Aliquot Stability	All analytes: 30 days at -20°C to -70°C
Shelf Life stability:	28 months at -20 to -70°C

9.0 Conclusion

Based on the performance characteristics indicated above, Liquichek Tumor Marker Control is substantially equivalent to the predicate device (K071675).

All supporting data is retained on file at Bio-Rad Laboratories.

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.