Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak

K163015 · Bio-Rad Laboratories · JJY · Jan 10, 2017 · Clinical Chemistry

Device Facts

• Record ID: K163015
• 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
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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. The following analytes are listed in the package insert: - 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 (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)

Device Story

Liquichek Tumor Marker Control is an assayed quality control serum; used by clinical laboratories to monitor precision of testing procedures for various tumor marker analytes. Product is prepared from human serum with added constituents of human/animal origin, stabilizers, and preservatives. Provided in liquid form in three levels or a trilevel minipak. Laboratory personnel use the control to verify assay performance; results are compared against provided value assignment charts to ensure testing accuracy. The modification adds Her-2/neu and HE4 to the existing analyte panel. Benefits include standardized quality monitoring for clinical diagnostic assays.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) were performed to establish shelf-life, thawed, and open-vial stability for the added analytes. Protocols and acceptance criteria were reviewed and found acceptable.

Technological Characteristics

Liquid quality control serum; human source material with animal-derived constituents, chemicals, stabilizers, and preservatives. Analyte list includes AFP, B2-M, CA 15-3, CA 19-9, CA 27.29, CA 125, CEA, Ferritin, Her-2/neu, hCG, HE4, IGF-1, PAP, Prolactin, Total PSA, Free PSA, and Thyroglobulin. Storage: -20°C to -70°C.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for tumor marker analytes in clinical laboratory settings.

Regulatory Classification

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.

Predicate Devices

• Liquichek Tumor Marker Control (K071675)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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 [phone] or [phone] 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 [phone] or [phone] 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 [phone] Telephone: [phone] Fax:

## Contact Person

Suzanne Parsons RA/QA Supervisor Telephone: [phone]

## 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

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.

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<br>(New Device) | Liquichek Tumor Marker Control<br>(Predicate Device, K071675) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Tumor Marker Control is intended for<br>use as an assayed quality control serum to<br>monitor the precision of laboratory testing<br>procedures for the analytes listed in this package<br>insert. | Liquichek Tumor Marker Control is intended for<br>use as an assayed quality control serum to<br>monitor the precision of laboratory testing<br>procedures for the analytes listed in this package<br>insert. |
| Matrix | Human source material and constituents of<br>animal origin | Human source material and constituents of<br>animal origin |
| Form | Liquid | Liquid |
| Storage unopened<br>(Shelf life) | -20°C to -70°C until expiration date | -20°C to -70°C until expiration date |
| Thawed Unopened<br>Stability | All analytes: 60 days at 2 to 8°C | All analytes: 60 days at 2 to 8°C |
| | <i>Except</i> IGF-I, PAP: 35 days at 2 to 8°C | <i>Except</i> 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 Opened<br>Stability | All analytes: 30 days at 2 to 8°C | All analytes: 30 days at 2 to 8°C |
| | <i>Except</i> IGF-1: 15 days at 2 to 8°C | <i>Except</i> 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) <b>Does not Contain:</b> 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°C<br>CA 125: 10 days at 2 to 8°C<br>All other analytes: 30 days at 2 to 8°C |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Thawed and Unopened Stability | IGF-I, PAP: 35 days at 2 to 8°C<br>Free PSA: 30 days at 2 to 8°C<br>CA 125: 14 days at 2 to 8°C<br>All 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.