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

Device Description

Lyphochek Tumor Marker Plus Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This control is substantially equivalent to the following quality control material that is currently in the market: Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California 92618 510(k) Number: K011579. The new device is lyophilized serum and has 3 levels (1, 2, and 3).

AI/ML Overview

This is a 510(k) premarket notification for a quality control material, not a diagnostic device that performs analysis on patient samples. Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance) are not applicable.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a quality control material, acceptance criteria typically relate to the stability of the analytes within the control. The studies performed are stability studies.

Acceptance Criteria (Stated Claims)	Reported Device Performance (Stability)
Shelf Life at 2 to 8°C: All analytes stable for 3 years.	All analytes are stable for 3 years at 2 to 8°C.
Reconstituted Stability at 2 to 8°C:	Once reconstituted and stored tightly capped at 2 to 8°C:
- All analytes stable for 14 days.	- All analytes stable for 14 days.
- CEA stable for 11 days.	- Carcinoembryonic Antigen (CEA) is stable for 11 days.
- Free and Total PSA stable for 7 days.	- Free and Total PSA are stable for 7 days.
- Thyroglobulin (Tg) stable for 5 days.	- Thyroglobulin (Tg) is stable for 5 days.
- ACTH and Calcitonin should be assayed immediately.	- ACTH and Calcitonin should be assayed immediately following reconstitution.
Reconstituted Stability at -20 to -70°C:	Once reconstituted and stored tightly capped at -20 to -70°C:
- All analytes stable for 30 days.	- All analytes are stable for 30 days. s-
- No stability claims for ACTH and Calcitonin at -20 to -70°C.	- There are no stability claims at -20 to -70°C for ACTH and Calcitonin.

2. Sample size used for the test set and the data provenance
The document refers to "Stability studies" as the basis for these claims. It does not provide specific sample sizes (e.g., number of vials, number of replicates, duration of storage for testing points) for these studies. It also does not specify the country of origin or whether they were retrospective or prospective, though stability studies for product claims are inherently prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a quality control material where "ground truth" refers to the expected concentration/stability of analytes, established through laboratory methods and internal validation, not expert interpretation of clinical data.

4. Adjudication method for the test set
Not applicable.

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
Not applicable. This is a quality control material, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material.

7. The type of ground truth used
The ground truth used for a quality control material like this would be derived from laboratory reference methods and certified reference materials, where applicable, to determine the assigned values and assess the stability of the included analytes over time and under various storage conditions. The stability studies (shelf life and reconstituted stability) are described as the basis for the performance claims.

8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device.

9. How the ground truth for the training set was established
Not applicable.

Summary

{0}------------------------------------------------

Bio-Rad Laboratories Lyphochek Tumor Marker Plus Control Premarket Notification Section 510(k)

1.0 DEVICE INFORMATION

Product Name:	Lyphochek Tumor Marker Plus Control
Common Name:	Clinical Chemistry Test Systems
:	Quality control material (assayed and unassayed)

2.0 MEDICAL DEVICE ESTABLISHMENT

Manufacturing Facility:	Bio-Rad Laboratories
Address:	9500 Jeronimo RoadIrvine, California 92618
Telephone:Fax:	949-598-1200949-598-1557

Establishment Registration No .: 2016706

3.0 DEVICE Class

Classification:	Class I
Product Code:	JJY
Regulation Number:	21 CFR 862.1660

4.0 Performance Standards

None Require

5.0 PROPOSED LABELING

Included in this 510(k) notification is a copy of the proposed Lyphochek Tumor Marker Plus Control vial, box and insert labels (Appendices 3, 4 and 5).

6.0 STATEMENT OF SUBSTANTIAL EQUIVALENCE

Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California 92618

510(k) Number: K011579

A copy of the product insert for the above product can be found in Appendix 7.

02_510(k) Lyp Tumor Markers_Plus_367 08/08

{1}------------------------------------------------

7.0 Comparison of the new device with the Predicate Device

Lyphochek Tumor Marker Plus Control claims substantial equivalence to the Lyphochek Tumor Marker Control currently in commercial distribution (K011579).

	Table 1. Similarities and Differences between new and predicate device.
	Bio-Rad Laboratories	Bio-Rad Laboratories
Characteristics	Lyphochek Tumor Marker Plus Control(New Device)	Lyphochek Tumor Marker Control(Predicate Device)
	Similarities
Intended Use	Lyphochek Tumor Marker Plus Control is intended for use asan assayed quality control serum to monitor the precision oflaboratory testing procedures for the analytes listed in thepackage insert.	Lyphochek Tumor Marker Control is intended for use as anassayed quality control serum to monitor the precision oflaboratory testing procedures for the analytes listed in thispackage insert.
Storage (Unopened)	3 Years at 2 to 8°C	3 Years at 2 to 8°C
Reconstitute & Storeat -20 to -70°C:	All analytes will be stable for 30 days at -20 to -70°C. Thereare no stability claims at -20 to -70°C for ACTH andCalcitonin.	All analytes will be stable for 30 days at -10 to -20°C with thefollowing exception: NSE will be stable for 7 days.
Form	Lyophilized	Lyophilized
Matrix	Serum	Serum
	Differences
Levels	1, 2 and 3	1 and 2
Reconstitute & Storeat 2 to 8°C	All analytes will be stable for 14 days at 2 to 8°C, with thefollowing exceptions:• Carcinoembryonic Antigen (CEA) is stable for 11 days.• Free and Total PSA is stable for 7 days.• Thyroglobulin (Tg) is stable for 5 days.• ACTH and Calcitonin should be assayed immediately.	All analytes will be stable for 14 days at 2 to 8°C, with thefollowing exceptions:• Ferritin and CA 27-29 will be stable for 6 days;• NSE will be stable for 3 days.• ACTH, Free PSA, PSA, and Calcitonin should be assayedimmediately following reconstitution.
Analytes	Contains Claims for the following:• Adrenocorticotropic Hormone (ACTH)• Alpha Fetoprotein (AFP)• Aldosterone• Beta-2-Microglobulin• CA 15-3• CA 19-9• CA 27.29• CA 125• Calcitonin• Carcinoembryonic Antigen (CEA)• Ferritin• hCG Beta Subunit (β-hCG)/ hCG• Prostatic Acid Phosphatase (PAP)• Prolactin• Prostate Specific Antigen, Total (PSA)• Prostate Specific Antigen, Free (Free PSA)• Thyroglobulin (Tg)	Contains Claims for the following:• Adrenocorticotropic Hormone (ACTH)• Alpha Fetoprotein (AFP)• Aldosterone• Beta-2-Microglobulin (B2-M)• CA 15-3• CA 19-9• CA 27.29• CA 50• CA 72-4• CA 125• Calcitonin• Carcinoembryonic Antigen (CEA)• CASA• Cyfra 21-1• Ferritin• Human Chorionic Gonadotropin (hCG)• Human Chorionic Gonadotropin Beta Subunit (β-hCG)• Neuron Specific Enolase (NSE)• Prostatic Acid Phosphatase (PAP)• Prolactin• Prostate Specific Antigen, Total (Total PSA)• Prostate Specific Antigen, Free (Free PSA)
	Does not contain claims for the following:• CA 50• CA 72-4• CASA• Cyfra 21-1	No claim is made for performance or stability

new and predicate device Table 1 Similarities and Differences betwee

{2}------------------------------------------------

8.0 STATEMENT OF SUPPORTING DATA

Stability studies have been performed to determine the shelf life at 2 to 8°C, reconstituted at 2 to 8°C and reconstituted frozen at -20 to -70°C. Product claims are as follows:

8.1 Shelf Life at 2 to 8°C, all analytes will be stable for 3 years.
8.2 Reconstituted Stability at 2 to 8°C: Once the control is reconstituted, all analytes will be stable for 14 days when stored tightly capped at 2 to 8°C, with the following exceptions: Carcinoembryonic Antigen (CEA) will be stable for 11 days; Free and Total PSA will be stable for 7 days: Thyroqlobulin (Tg) will be stable for 5 days; ACTH and Calcitonin should be assayed immediately following reconstitution.
8.3 Reconstituted Stability at -20 to -70°C: All analytes will be stable for 30 days after the control is reconstituted and stored tightly capped at -20 to -70℃. After use, discard the remaining material. There are no stability claims at -20 to -70°C for ACTH and Calcitonin.

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

.. ... .......................................................................................................................................................................

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tails, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP - 8 2008

Bio-Rad Laboratories c/o Ms. Elizabeth Platt 9500 Jeronimo Road Irvine, California 92618-2017

Re: K082036

Trade/Device Name: Lyphochck Tumor Marker Plus Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I reserved Product Code: JJY Dated: July 1, 2008 Received: July 17, 2008

Dear Ms. Platt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); 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.

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

{4}------------------------------------------------

Page 2- Bio-Rad Laboratories

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)). please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Maria Mchen

Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

K 082036 510(k) Number (if known):

Device Name:

Indications For Use:

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

Domestic Analytes Listed

· Adrenocorticotropic Hormone (ACTH)
Lyphochek Tumor Marker Plus Control
· Alpha Fetoprotein (AFP)
· Aldosterone
· Beta-2-Microglobulin (B2M)
· CA 15-3
· CA 19-9
· CA 27.29
· CA 125
· Calcitonin
· Carcinoembryonic Antigen (CEA)
· Ferritin
· hCG Beta Subunit (ß-hCG)/ hCG
· Prostatic Acid Phosphatase (PAP)
· Prolactin
· Prostate Specific Antigen, Total ( PSA)
· Prostate Specific Antigen, Free (Free PSA)
· Thyroglobulin (Tg)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reena Philip

Division Sign-Off

ice of In Vitro Diagnostic e Evaluation and Safety

Page 1 of

510(k) K082036

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.