Liquichek Spinal Fluid Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Description

Liquichek Spinal Fluid Control is a human based control with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.

Each human donor unit used to manufacture this control was tested by FDA accepted methods and found to be non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-Rad Liquichek Spinal Fluid Control:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Open Vial Stability	30 days at 2 to 8°C
Shelf Life Stability	2 Years at 2 to 8°C

Note: The document explicitly states that "Stability studies have been performed and acceptance criteria were met for Liquichek Spinal Fluid Control to determine the stability claims." This implies the reported device performance is the acceptance criteria that was met. The specific quantitative acceptance criteria (e.g., within X% of initial value, acceptable range of CV) are not detailed in this summary document.

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "replicate analyses" and "a representative sampling of this lot of product" when describing how mean values and ±3SD ranges were derived for value assignment. For stability studies, the document only states "Stability studies have been performed," without specifying the number of samples or runs.
- Data Provenance: The document does not specify the country of origin for the data. The studies were performed by the manufacturer (Bio-Rad Laboratories) and/or independent laboratories. The data is retrospective in the sense that the studies were completed before the 510(k) submission, but the design of new stability studies would typically involve prospective testing over time for the specific product lot.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quality control material, not a diagnostic device that requires expert interpretation of results or establishment of a "ground truth" in the clinical sense. The "ground truth" for a control material is typically its assigned value and expected stability, determined through rigorous analytical testing rather than expert clinical consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As a quality control material, clinical adjudication methods are not relevant. The "ground truth" (assigned values, stability) is established through analytical methods.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, i.e., how much human readers improve with AI vs without AI assistance: Not applicable. This device is a quality control material, not an AI-powered diagnostic tool. No human reader performance or AI assistance is involved.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a quality control material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this quality control material is its assigned values and stability characteristics, which are determined through:
- Replicate analyses: Performed by the manufacturer and/or independent laboratories using manufacturer-supported reagents and a representative sampling of the product lot.
- Stability studies: Conducted to determine the open vial and shelf life stability claims.
The sample size for the training set: Not applicable. This device is a biochemical control, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary

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123775

Bio-Rad Laboratories Premarket Notification Section 510 (k) Liguichek Spinal Fluid Control 510(k) Summary

Page 1 of 3

510(k) Summary Liquichek Spinal Fluid Control

1.0 Submitter

JAN 3. 1 2013

Bio-Rad Laboratories 9500 Jeronimo Road. Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557

Contact Person

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

Date of Summary Preparation

January 28, 2013

2.0 Device Identification

Product Trade Name:	Liquichek Spinal Fluid Control
Common Name:	Multi-Analyte Controls, All Kinds (Assayed)
Review Panel:	Clinical Chemistry and Clinical Toxicology Devices
Classifications:	Class I, Reserved
Product Code:	JJY
Regulation Number:	21 CFR 862.1660

3.0 Device to Which Substantial Equivalence is Claimed

Liquichek Spinal Fluid Control Bio-Rad Laboratories Irvine, California

510 (k) Number: K990888

4.0 Description of Device

Level	Catalog Number	Configuration
Level 1	303	6 x 2.5 mL
Level 2	304	6 x 2.5 mL
Bilevel MiniPak	302X	2 x 2.5 (1 per level) mL

Table 1: Product Catalog Description

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5.0 Value Assignment

The mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses and are specific for this lot of 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 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 Splnal Fluid Control is intended for use as an assayed quality control material 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

The new Liquichek Spinal Fluid Control claims substantial equivalence to the Liquichek Spinal Fluid Control currently in commercial distribution (K990888). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

Characteristics	Liquichek Spinal Fluid Control(New Device)	Liquichek Spinal Fluid Control(Predicate Device, K990888)
	Similarities
Intended Use	Liquichek Spinal Fluid Control is Intended for useas an assayed quality control material to monitorthe precision of laboratory testing procedures forthe analytes listed in the package insert.	Liquichek Spinal Fluid Control is intended for useas an assayed quality control material to monitorthe precision of laboratory testing procedures forthe analytes listed in the package insert.
Form	Liquid	Liquid
Matrix	Diluted Human serum	Diluted Human serum
Storage Unopened(Shelf life)	At 2 - 8 °C until the expiration date	At 2 - 8 °C until the expiration date
Differences
Fill Volume	2.5 mL	3 mL
Open Vial Stability	30 days at 2 - 8 °C on board Siemens DimensionVista instrument	30 days at 2 - 8 °C
Analytes	Contains:AlbuminChlorideGlucoseImmunoglobulin G (IgG)Lactate(Lactic Acid)Lactate Dehydrogenase (LDH)Protein TotalSodiumDoes not contain:Immunoglobulin M (IgM)Globulin ( $\alpha_1$ , $\alpha_2$ , β, γ)Immunoglobulin A (IgA)	Contains:AlbuminChlorideGlucoseImmunoglobulin G (IgG)Lactate(Lactic Acid)Lactate Dehydrogenase (LDH)Protein TotalSodiumImmunoglobulin M (IgM)Globulin ( $\alpha_1$ , $\alpha_2$ , β, γ)Immunoglobulin A (IgA)

Table 1: Simllarlies and Differences between the new and predicate device

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8.0 Statement of Supporting Data

Stability studies have been performed and acceptance criteria were met for Liquichek Spinal Fluid Control to determine the stability claims. Product claims are as follows:

Open Vial:	30 days at 2 to 8°C
Shelf Life Stability:	2 Years at 2 to 8°C

9.0 Conclusion

Based on the performance characteristics indicated above, Bio-Rad's Liquichek Spinal Fluid Control is substantially equivalent to the predicate device K990888.

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

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DEPARTMENT OF HEALTH & HUM AN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an image of a stylized eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G Silver Spring, MD 20993-002

January 31, 2013

Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K123775

Trade/Device Name: Liquichek Spinal Fluid Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material Regulatory Class: Class I, Reserved Product Code: JJY Dated: December 6, 2012 Received: December 10, 2012

Dear Ms. Suzanne 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.

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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Page 2 -- Suzanne Parsons

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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.goy/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/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson

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

for

Enclosure

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Indications for Use Form

510(k) Number (if known): K123775

Device Name:

Liquichek Spinal Fluid Control

Indications for Use:

Liquichek Spinal Fluid Control is intended for use as an assayed quality control material 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:

Albumin
Chloride
Glucose
Immunoglobulin G (IgG)
Lactate (Lactic Acid) A

Lactate Dehydrogenase (LDH) A

Protein Total

Sodium

Prescription Use	X
(21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use
(21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung W/. Chan -S

Division Sign-Off

Office of In Vitro Diagnostics and Radiological Health (OIR)

510(k)_k123775

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.