LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL

K133960 · Bio-Rad Laboratories · JJY · Jan 22, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133960
• Device Name: LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Lyphochek Specialty Immunoassay 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 Story

Lyphochek Specialty Immunoassay Control is a human serum-based, lyophilized quality control material containing stabilizers and preservatives. It is designed for use in clinical laboratories to monitor the precision of immunoassay testing procedures for specific analytes: Erythropoietin (EPO), Procalcitonin, Intact Parathyroid Hormone (Intact PTH), Sex Hormone Binding Globulin (SHBG), and Vitamin D. The device is provided in multiple levels to allow for multi-point monitoring of assay performance. Laboratory personnel reconstitute the lyophilized material and process it alongside patient samples using standard laboratory instrumentation and reagents. The resulting values are compared against the provided mean and ±3SD ranges to assess the stability and accuracy of the testing system over time. By identifying potential variations in laboratory technique, instrumentation, or reagent performance, the control helps ensure the reliability of clinical diagnostic results, ultimately supporting accurate patient diagnosis and management.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) were conducted to establish shelf life (36 months at 2-8°C), reconstituted vial stability, and frozen aliquot stability. Mean values and ±3SD ranges were derived from replicate analyses using manufacturer-supported reagents.

Technological Characteristics

Human serum-based control; lyophilized form; contains stabilizers and preservatives. Analyte list: EPO, Procalcitonin, Intact PTH, SHBG, Vitamin D. Storage: 2-8°C. Reconstituted stability varies by analyte (3-30 days).

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes (Erythropoietin, Procalcitonin, Intact PTH, SHBG, Vitamin D) 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.

Submission Summary (Full Text)

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## 510(k) Summary

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92

# Lyphochek Specialty Immunoassay Control . 510(k) Number: k133960

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: [phone] · [phone] Fax:

## Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: [phone]

Email: Suzanne [e-mail]

## Date of Summary Preparation

January 10, 2014

#### 2.0 Device Identification

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

Lyphochek Specialty Immunoassay 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 Specialty Immunoassay Control

510(k) Number: k043108

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#### ' 4.0 Intended Use

Lyphochek Specialty Immunoassay 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.

#### Description of Device 5.0

Lyphochek Specialty Immunoassay Control is prepared from human serum with added chemicals, stabilizers, and preservatives. The control is provided in lyophilized form and contains the following analytes:

- Erythropoietin (EPO) .
- Procalcitonin .
- . Intact Parathyroid Hormone (Intact PTH)
- Sex Hormone Binding Globulin (SHBG) .
- Vitamin D .

Each human donor unit 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.

Product Configurations

| Description | Configuration |
|-----------------------------------------------------------|---------------|
| Lyphochek Specialty Immunoassay Control, Level 1 | 6 x 2 mL |
| Lyphochek Specialty Immunoassay Control, Level 2 | 6 x 2 mL |
| Lyphochek Specialty Immunoassay Control, Level 3 | 6 x 2 mL |
| Lyphochek Specialty Immunoassay Control, Trilevel MiniPak | 3 x 2 mL |

#### 6.0 Value Assignment

The mean values and the corresponding ±3SD ranges indicated on the control value sheet provided for Lyphockek Specialty Control were derived from replicate analyses and are specific for each lot of product. The tests listed on the control value sheet were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of the 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.

#### 7.0 Comparison of the new device with the Predicate Device

Lyphochek Specialty Immunoassay Control claims substantial equivalence to the Liquichek Specialty Immunoassay Control currently in commercial distribution (k043108): The table below contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

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| Characteristics | Lyphochek Specialty Immunoassay Control<br>(Candidate Device) | Liquichek Specialty Immunoassay Control<br>(Predicate Device, k043108) |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Lyphochek Specialty Immunoassay Control is<br>intended for use as an assayed quality<br>control serum to monitor the precision of<br>laboratory testing procedures for the analytes<br>listed in the package insert. | Liquichek Specialty Immunoassay Control<br>is intended for use as a quality control<br>serum to monitor the precision of laboratory<br>testing procedures for the analytes listed in<br>this package insert. |
| Matrix | Human Serum | Human Serum |
| Preservatives | Contains preservatives | Contains preservatives |
| Stabilizers | Contains stabilizers | Contains stabilizers |
| Differences | | |
| Form | Lyophilized | Liquid |
| Storage unopened (Shelf<br>life) | 2 to 8°C until expiration date | -20 to -70°C until expiration date |
| Reconstituted / Opened Vial<br>Stability | 30 days at 2°C to 8 °C<br>Except: Intact PTH: 12 days at 2°C to<br>8 °C<br>> Procalcitonin: 3 days at 2°C<br>to 8 °C | 30 days at 2°C to 8 °C<br>Except: Intact PTH: 23 days at 2 to<br>8°C |
| Fill Volume | 2 mL | 5 mL |
| | MiniPak: Trilevel - 3 x 2 mL | MiniPak: Four level - 4 x 5 mL |
| Frozen Aliquot stability | All analytes : 30 days at -20°C to -70°C | No Claim |
| Analytes | Contains:<br>Erythropoietin (EPO) Procalcitonin Intact Parathyroid Hormone (Intact PTH) Sex Hormone Binding Globulin (SHBG) Vitamin D Does not contain: Anti-Thyroglobulin (Anti-Tg) Anti-Thyroperoxidase (Anti-TPO) C-Peptide Insulin Like Growth Factor I (IGF-I) Osteocalcin | Contains:<br>Anti-Thyroglobulin (Anti-Tg) Anti-Thyroperoxidase (Anti-TPO) C-Peptide Insulin Like Growth Factor I (IGF-I) Intact Parathyroid Hormone (Intact PTH) 25-OH Vitamin D Osteocalcin Erythropoietin (EPO) Does not contain: Procalcitonin Sex Hormone Binding Globulin (SHBG) |

Similarities and Differences between new and predicate device

· ·

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#### 8.0 Stability

Real time stability studies were performed to establish reconstituted/open vial stability and frozen aliquot stability. Accelerated stability studies were performed for establishing the shelf life stability. The stabilities for Lyphochek Specialty Immunoassay Control are as follows:

| | Reconstituted Vial Stability: Intact Parathyroid Hormone (Intact PTH): 12 days at 2°C to 8°C<br>Procalcitonin: 3 days at 2°C to 8 °C<br>Erythropoietin (EPO), Sex Hormone Binding Globulin (SHBG)<br>and Vitamin D: 30 days at 2 to 8°C |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Frozen Aliquot Stability: | 30 days at -20°C to -70°C |
| Shelf Life Stability: | 36 Months at 2 to 8°C |

#### 9.0 Conclusion

Based on the performance characteristics indicated above, Lyphochek Specialty Immunoassay Control is substantially equivalent to the predicate device (k043108).

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

January 22, 2014

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

Re: K133960

Trade/Device Name: Lyphochek Specialty Immunoassay Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I Reserved Product Code: JJY Dated: December 20, 2013 Received: December 24, 2013

## Dear Ms. Parsons:

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

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Page 2-Ms. Parsons

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

### 510(k) Number (if known) K133960

## Device Name

Lyphochek Specialty Immunoassay Control

## Indications for Use (Describe)

Lyphochek Specialty Immunoasay 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.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (1/14)

PSC Publishing Berrines (IP)) 443-6740

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