Liquichek Maternal Serum II 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

Liquichek Maternal Serum II Control is prepared from defibrinated human plasma with added constituents of human origin, chemicals, stabilizers, and preservatives. The control is provided in liquid form for convenience.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) premarket notification for a Class I quality control material. For such devices, the primary "acceptance criteria" relate to demonstrating substantial equivalence to a legally marketed predicate device rather than specific clinical performance metrics like sensitivity or specificity.

The acceptance criteria for this device, the Liquichek Maternal Serum II Control, were primarily focused on demonstrating its suitability as an assayed quality control serum by comparing its characteristics and performance to a predicate device, the Lyphochek Maternal Serum Control (K984594). The key performance aspects evaluated were:

Intended Use: The new device must have the same intended use as the predicate.
Base Matrix: The fundamental composition should be comparable.
Stability: The device must demonstrate adequate stability (thawed, opened, and shelf-life) to ensure its utility as a control material.
Analytes: The device should contain the analytes relevant to its intended use and listed on the package insert, similar to or expanded from the predicate.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Characteristic	Predicate Device (Lyphochek Maternal Serum Control, K984594)	New Device (Liquichek Maternal Serum II Control)	Outcome/Performance
Intended Use	Assayed quality control serum to monitor precision for listed analytes.	Assayed quality control serum to monitor precision for listed analytes.	Same Intended Use
Base Matrix	Defibrinated Human Plasma	Defibrinated Human Plasma	Same
Form	Lyophilized	Liquid	Difference (Liquid is a manufacturing difference, not a failure of acceptance)
Fill Size	5 mL	2.5 mL	Difference (Manufacturing difference)
Thawed and Unopened Stability	No claims made	40 days at 2 to 8°C	Established
Thawed and Opened Stability	10 days at 2 to 8°C / After Reconstitution	30 days at 2 to 8°C	Improved (Extended stability)
Shelf Storage & Stability	2 to 8°C until expiration date	-20 to -70°C until expiration date (40 months)	Difference (Different storage conditions/duration, but established)
Analytes	AFP, hCG, Estriol, Free	AFP, hCG, Unconjugated Estriol, Inhibin A	Expanded (New device includes Inhibin A)
Value Assignment	Established by replicate analyses with manufacturer/independent labs.	Established by replicate analyses with manufacturer/independent labs.	Same methodology

Study Proving Device Meets Acceptance Criteria

The study described is a comparison study to demonstrate substantial equivalence to the predicate device, along with stability studies to establish the shelf life and in-use stability of the new control material.

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

Test Set Sample Size: The document does not specify a numerical sample size for the test set in terms of cases or individual control units used for the comparison or stability studies. It states that mean values and ranges were derived from "replicate analyses," and "a representative sampling of this lot of product" was used. For stability, "real time stability studies" and "accelerated stability studies" were performed.
Data Provenance: The studies were performed internally by Bio-Rad Laboratories or by "independent laboratories." The country of origin of the data is implied to be related to Bio-Rad Laboratories' operations, which is based in Irvine, California, USA. The studies are prospective in nature, as they are conducted on the newly manufactured device to establish its performance and stability claims.

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, not a diagnostic medical device that interprets patient data. Therefore, there is no "ground truth" in the clinical sense established by human experts. The "truth" for this device relates to its known analyte concentrations and its stability characteristics. The "value assignment" for the analytes is performed through analytical testing by the manufacturer and/or independent laboratories, not by expert consensus on clinical findings.

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

Not Applicable. As explained above, this device does not involve human interpretation of clinical data that would require an adjudication method. The performance is assessed through analytical measurements and comparison to predefined specifications (i.e., stability protocols, value assignment procedures).

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 and not an AI-powered diagnostic device. Therefore, MRMC studies are not relevant to its evaluation.

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

Not Applicable. This device is a biochemical control material, not an algorithm or software. Its performance is inherent to its chemical composition and stability.

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

The "ground truth" in the context of a quality control material refers to the assigned target values and acceptable ranges for each analyte within the control. This "truth" is established through replicate quantitative analytical measurements using validated methods by the manufacturer and/or independent laboratories, rather than expert consensus on clinical data or pathology. The stability ground truth is established through real-time and accelerated stability studies monitoring analyte concentrations over time under specified storage conditions.

8. The sample size for the training set

Not Applicable. As a quality control material, this device does not involve machine learning or AI, and therefore, no "training set" is used. Its development and characterization rely on established laboratory manufacturing and analytical testing procedures.

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

Not Applicable. See point 8.

Summary

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

March 13, 2015

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

Re: K143379

Trade/Device Name: Liquichek Maternal Serum II Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Code: JJY Dated: February 9, 2015 Received: February 11, 2015

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 Part 801); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/Resourcesfor You/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 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 vours.

Katherine Serrano -A

For : 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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Indications for Use

510(k) Number (if known) K143379

Device Name Liquichek Maternal Serum II Control

Indications for Use (Describe)

Liquichek Maternal Serum II 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.

Analytes are: AFP hCG Unconjugated Estriol Inhibin A

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)

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

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510(k) Summary

Liquichek Maternal Serum II Control

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

Date of Summary Preparation

March 12, 2015

2.0 Device Identification

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

Liquichek Maternal Serum II Control Multi-Analyte Controls, All Kinds (Assayed) Class I, Reserved JJY 21 CFR 862.1660

3.0 Device to Which Substantial Equivalence is Claimed

Lyphochek Maternal Serum Control Bio-Rad Laboratories Predicate 510(k) Number: K984594

4.0 Description of Device

Table 1: Product Catalog Description

Level	Configuration
Liquichek Maternal Serum II Control Level 1	6 x 2.5 mL
Liquichek Maternal Serum II Control Level 2	6 x 2.5 mL
Liquichek Maternal Serum II Control Level 3	6 x 2.5 mL
Liquichek Maternal Serum II Control Trilevel MiniPak	3 x 2.5 mL(1 vial per level)

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.

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5.0 Intended Use

Liquichek Maternal Serum II 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.

6.0 Comparison of the New Device with the Predicate Device

Liquichek Maternal Serum II Control claims substantial equivalence to Lyphochek Maternal Serum Control (K984594). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

Liquichek Maternal Serum II Lyphochek Maternal Serum Characteristics Control Control (New Device) (Predicate Device, K984594) Similarities Liquichek Maternal Serum II Same Intended Use 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. Base Matrix Defibrinated Human Plasma Same Differences Form Liquid Lyophilized Fill Size 2.5 mL 5 mL Thawed and 40 days at 2 to 8°C No claims made Unopened Stability Thawed and Opened Vial 30 days at 2 to 8°C 10 days at 2 to 8°C / After Reconstitution Shelf Storage & -20 to -70°C until the expiration 2 to 8°C until the expiration date Stability (Unopened) date Analytes Contains: Contains: AFP AFP hCG hCG Estriol, Free Estriol, Free Inhibin A Does not contain: Inhibin A

a Table 2: Similarities and Differences Between the New Device and the Predicate Device

7.0 Traceability:

The analytes contained in the Liquichek Maternal Serum II Control are obtained from commercially available sources, except for Inhibin A which is internally sourced.

8.0 Value Assignment

The mean values and corresponding ±3SD ranges printed in the insert were derived from replicate analyses and are specific for the lot of the product. 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

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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.

9.0 Stability:

Real time stability studies were performed to establish thawed (opened and unopened vial) stability claims. Accelerated stability studies were performed to establish the shelf life stability claims with real-time stability ongoing. The stabilities for Liquichek Maternal Serum II Control are as follows:

Thawed and Unopened Stability	40 days at 2 to 8°C
Thawed and opened Stability	30 days at 2 to 8°C
Shelf Life Stability:	40 months at -20 to -70°C

10.0 Conclusion

Based on the performance characteristics indicated above, Liquichek Maternal Serum II Control is substantially equivalent to the predicate device (K984594).

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.