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 Description

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.

AI/ML Overview

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Device Acceptance Criteria and Study Details: Lyphochek Specialty Immunoassay Control

This 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with pre-defined acceptance criteria for performance. The "acceptance criteria" here is implicitly demonstrated through the comparison of characteristics and the stability studies, showing the new device performs comparably and safely.

The Lyphochek Specialty Immunoassay Control is a quality control serum intended to monitor the precision of laboratory testing procedures for a list of analytes.

1. Table of Acceptance Criteria and Reported Device Performance

Since the submission is for substantial equivalence, the "acceptance criteria" are implied by demonstrating comparability to the predicate device and establishing appropriate stability profiles. The device performance is primarily described in terms of its stability characteristics.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Functional Equivalence: Device must perform its intended use (monitor precision of laboratory testing) comparably to the predicate device.	Demonstrated through "Value Assignment" process: Mean values and ±3SD ranges derived from replicate analyses, specific for each lot, using manufacturer-supported reagents and representative sampling. This implies the control will generate expected values.
Matrix Compatibility: Human serum matrix, similar to predicate.	Device matrix is Human Serum, identical to predicate.
Preservation & Stabilization: Contains preservatives and stabilizers, similar to predicate.	Device contains preservatives and stabilizers, identical to predicate.
Shelf Life Stability: Maintain integrity and expected values when unopened and stored under recommended conditions for a specified period.	Shelf Life Stability: 36 Months at 2 to 8°C (Established via Accelerated Stability Studies).
Reconstituted/Opened Vial Stability: Maintain integrity and expected values for a specified period after reconstitution/opening under recommended storage conditions.	Reconstituted Vial Stability: - Intact PTH: 12 days at 2°C to 8°C - Procalcitonin: 3 days at 2°C to 8°C - Erythropoietin (EPO), Sex Hormone Binding Globulin (SHBG), and Vitamin D: 30 days at 2 to 8°C (Established via Real-Time Stability Studies).
Frozen Aliquot Stability: Maintain integrity and expected values for a specified period when aliquoted and frozen under recommended storage conditions (new claim for candidate device).	Frozen Aliquot Stability: 30 days at -20°C to -70°C for all analytes (Established via Real-Time Stability Studies).
Safety: Manufacturing process for human-derived components ensures safety (e.g., non-reactive for major blood-borne pathogens).	Each human donor unit tested by FDA accepted methods and found non-reactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2.
Configuration: Appropriate packaging and fill volume for intended use (differences from predicate are noted but must be clinically acceptable).	Lyophilized form, 2 mL fill volume (MiniPak: Trilevel - 3 x 2 mL). These are noted differences from the predicate but are considered acceptable.
Analyte Content: Must contain the specified analytes and not contain analytes that would negatively impact its function as a control for its specified targets (differences from predicate are noted but must be clinically acceptable). Also, new analytes must have stability data.	Contains: EPO, Procalcitonin, Intact PTH, SHBG, Vitamin D. Does not contain: Anti-Tg, Anti-TPO, C-Peptide, IGF-I, Osteocalcin. These are noted differences from the predicate but are considered acceptable, with stability data provided for the new analytes.

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

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a diagnostic accuracy study. The data provenance for the stability studies and value assignment involves "replicate analyses" and "representative sampling of the lot of product." The specific number of replicates or samples is not provided in this summary.
Data Provenance: The studies were performed by the manufacturer and/or independent laboratories. No country of origin is explicitly stated, but the manufacturer is Bio-Rad Laboratories in Irvine, California, USA. The data would be prospective in nature, as it involves the testing of the manufactured control product.

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

Number of Experts: Not applicable. This device is a quality control (QC) material, not a diagnostic device that produces patient-specific results requiring expert interpretation or "ground truth" establishment in that sense.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is a quality control product, not a diagnostic device where expert adjudication of results is necessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This device is a quality control material and not an AI-assisted diagnostic tool. Therefore, an MRMC study and effect size of AI assistance are not relevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Not applicable. This is a physical quality control material and does not involve an algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: For the "Value Assignment" of the control, the "ground truth" is established by generating mean values and corresponding ±3SD ranges through replicate analyses using manufacturer supported reagents and a representative sampling of the product lot. This is akin to a reference method or consensus measurement within the laboratory setting for defining the expected range of the control. For the primary purpose of this submission (substantial equivalence), the "ground truth" is the performance of the legally marketed predicate device.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a quality control material and does not employ a machine learning algorithm that requires a "training set."

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an algorithm.

Summary

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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: (949) 598-1200 · (949) 598-1557 Fax:

Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467

Email: Suzanne Parsons@bio-rad.com

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

Description of Device 5.0

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(Candidate Device)	Liquichek Specialty Immunoassay Control(Predicate Device, K043108)
Similarities
Intended Use	Lyphochek Specialty Immunoassay Control isintended for use as an assayed qualitycontrol serum to monitor the precision oflaboratory testing procedures for the analyteslisted in the package insert.	Liquichek Specialty Immunoassay Controlis intended for use as a quality controlserum to monitor the precision of laboratorytesting procedures for the analytes listed inthis package insert.
Matrix	Human Serum	Human Serum
Preservatives	Contains preservatives	Contains preservatives
Stabilizers	Contains stabilizers	Contains stabilizers
Differences
Form	Lyophilized	Liquid
Storage unopened (Shelflife)	2 to 8°C until expiration date	-20 to -70°C until expiration date
Reconstituted / Opened VialStability	30 days at 2°C to 8 °CExcept: Intact PTH: 12 days at 2°C to8 °C> Procalcitonin: 3 days at 2°Cto 8 °C	30 days at 2°C to 8 °CExcept: Intact PTH: 23 days at 2 to8°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: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: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°CProcalcitonin: 3 days at 2°C to 8 °CErythropoietin (EPO), Sex Hormone Binding Globulin (SHBG)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 (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" (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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (1/14)

PSC Publishing Berrines (IP)) 443-6740

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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.