Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.
Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Description

Quest Diagnostics Serum Chemistry Control is prepared from human serum to which purified biochemical materials (tissue extracts of human and animal origin), chemicals, preservatives, and stabilizers have been added.

AI/ML Overview

The provided text describes a "Summary of Safety and Effectiveness" for the Quest Diagnostics Serum Chemistry Control, a quality control material. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve AI, human readers, or image analysis. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted or deduced from the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (K033387). The performance is characterized by its intended use, form, matrix, other ingredients, and stability claims, which are compared to the predicate.

Acceptance Criteria Category	Predicate Device Performance	New Device Performance	Notes
Intended Use	Quality control serum to monitor precision of automated and manual testing procedures.	Quality control serum to monitor precision of automated and manual testing procedures.	Similar
Form	Liquid	Liquid	Similar
Matrix	Human serum based	Human serum based	Similar
Other Ingredients	Stabilizers and preservatives	Stabilizers and preservatives	Similar
Open Vial Claim	30 days at 2-8°C	30 days at 2-8°C	Similar
Shelf Storage Claim (Unopened)	Max 2 years at -10°C to -20°C	Max 2 years at -20°C to -70°C (with ongoing real-time studies)	New device has a different, broader temperature range for long-term storage.
Alternate Storage Claim (Unopened)	None	6 months at -10°C to -20°C	New device has an additional alternate storage claim.
Analytes	Contains 30 analytes (listed). Does not contain LDL.	Contains 31 analytes (listed). Includes LDL.	New device has an added claim for LDL.

Study Information

The document describes stability studies as the primary supporting data for the device's claims.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the sample size (number of control units or replicates) used for the stability studies.
- The data provenance is from Bio-Rad Laboratories, Irvine, California, USA.
- The stability studies are described as "Real time studies will be ongoing," which implies they are prospective for the shelf life claim, while the initial open-vial and alternate stability claims would have sufficient data to be submitted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. This is a quality control material for chemical testing, not a diagnostic device requiring expert interpretation of results. The "ground truth" for chemical controls is established through rigorous laboratory testing against reference methods or certified reference materials, not expert consensus in the typical medical imaging sense.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this type of adjudication is not relevant for chemical control materials. Quality control performance is assessed against established statistical limits and analytical targets.
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 device is a quality control material for laboratory instruments, not an AI-assisted diagnostic tool or a human-read diagnostic test.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device. Its performance is intrinsic to the chemical stability and composition of the control material.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a quality control material like this, the "ground truth" for its performance (e.g., stability over time) would be established by analytical measurements using validated laboratory methods and potentially comparison to certified reference materials or industry standards. The document states "All supporting data is retained on file at Bio-Rad Laboratories," indicating internal validation.
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. As above, no training set is involved.

Summary

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Summary of Safety and Effectiveness Quest Diagnostics Serum Chemistry Control

1.0 Submitter

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

Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367

Date of Summary Preparation

October 26, 2007

2.0 Device Identification

Product Trade Name:	Quest Diagnostics Serum Chemistry Control
Common Name:	Multi-Analyte Controls, (Assayed and Unassayed)

CFR 862.1660

Class I

JJY

Classifications: Product Code: Regulation Number:

3.0 Device to Which Substantial Equivalence is Claimed

Bio-Rad Laboratories Quest Diagnostics Serum Chemistry Control Irvine, California Docket Number: K033387

4.0 Description of Device

5.0 Statement of Intended Use

Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.

6.0 Comparison of the new device with the Predicate Device

Quest Diagnostics Serum Chemistry Control claims substantial equivalence to the Quest Diagnostics Serum Chemistry Control currently in commercial distribution (K033387). The new Quest Diagnostics Serum Chemistry Control contains the claims for the same analytes as the predicate device, with the addition of new claims for LDL.

K073080

JAN 2 4 2008

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Table 1. Similarities and Differences between new and predicate device.
	Quest Diagnostics	Quest Diagnostics
Characteristics	Serum Chemistry Control(New Device)	Serum Chemistry Control(Predicate Device)
Similarities
Intended Use	Quest Diagnostics Serum Chemistry Control is intendedfor use as a quality control serum to monitor theprecision of an individual laboratory's automated andmanual-testing procedures.	Quest Diagnostics Serum Chemistry Control isintended for use as a quality control serum to monitorthe precision of an individual laboratory's automatedand manual-testing procedures.
Form	Liquid	Liquid
Matrix	Human serum based	Human serum based
Other ingredients	Stabilizers and preservatives	Stabilizers and preservatives
Open Vial Claim	30 days at 2-8°C	30 days at 2-8°C
Differences
Shelf StorageClaim (Unopened)	-20°C to -70°CUntil expiration date	-10°C to -20°CUntil expiration date
Alternate StorageClaim (Unopened)	6 months at -10°C to -20°C	None
Analytes	Contains:- Alanine Aminotransferase- Albumin- Alkaline Phosphatase (ALP)- Amylase- Aspartate Aminotransferase(AST/SGOT)- Bilirubin, Direct- Bilirubin, Total- Blood Urea Nitrogen- Calcium- Chloride- Cholesterol- Cholesterol, HDL- CO2- Creatine Kinase (CK)- Creatinine- Low Density Lipoprotein (LDL)	- Gamma-Glutamyltransferase- Glucose- Iron- Iron-Binding Capacity,Unsaturated (UIBC)- Lactate Dehydrogenase(LDH)- Lipase- Magnesium- Phosphorous- Potassium– Sodium- Thyroxine (T4)- T3 Uptake- Total Protein- Triglycerides- Uric Acid	Contains:- Alanine Aminotransferase- Albumin- Alkaline Phosphatase (ALP)- Amylase- Aspartate Aminotransferase(AST/SGOT)- Bilirubin, Direct- Bilirubin, Total- Blood Urea Nitrogen- Calcium- Chloride- Cholesterol- Cholesterol, HDL- CO2- Creatine Kinase (CK)- Creatinine	- Gamma-Glutamyltransferase- Glucose- Iron- Iron-Binding Capacity,Unsaturated (UIBC)- Lactate Dehydrogenase(LDH)- Lipase- Magnesium- Phosphorous- Potassium- Sodium- Thyroxine (T4)- T3 Uptake- Total Protein- Triglycerides- Uric AcidDoes not contain:- LDL

7.0 Statement of Supporting Data

Stability studies have been performed to determine the open vial stability and shelf life for the Quest Diagnostics Serum Chemistry Control. Product claims are as follows:

. Open vial: 30 days when stored tightly capped at 2-8°C.
. Alternate Stability (Closed vial): 6 months when stored at -10 to -20°C.
. Shelf Life: Two years when stored at -20 to -70°C.

Real time studies will be ongoing to support the shelf life of this product.

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

08_SSE_Quest Serum Chemistry_591 10/07

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping, curved lines forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

JAN 2 4 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bio-Rad Laboratories c/o Ms. Maria Zeballos Regulatory Affairs Specialist 9500 Jeronimo Road Irvine, CA 92618-2017

K073080 Re:

Trade Name: Quest Diagnostics Serum Chemistry Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: December 10, 2007 Received: December 17, 2007

Dear Ms. Zeballos:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Ko73080

Device Name:

Indications For Use:

Quest Diagnostics Serum Chemistry Control

Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

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)

Carol C. Benson
Sign-Off

Page 1 of

Of In Vitro Diagnostic Device ation and Safety

K073080

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.