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

Here's an analysis of the provided text regarding the Quest Diagnostics Serum Chemistry Control, focusing on acceptance criteria and study details:

This device is a Quality Control (QC) material, not a diagnostic device that produces patient results or relies on AI. Therefore, many of the requested fields (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training set) are not applicable to this type of product.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria (Claimed Performance)	Reported Device Performance
Intended Use	To monitor the precision of an individual laboratory's automated and manual-testing procedures.
Open Vial Stability (Unopened Frozen)	10 days when stored tightly capped at 2-8°C.
Shelf Life (Unopened Frozen)	Two years when stored at -10 to -20 °C.
Form	Liquid
Matrix	Human serum based
Other Ingredients	Stabilizers and preservatives
Analytes	ALT, Albumin, Alkaline Phosphatase, Amylase, AST, Direct Bilirubin, Total Bilirubin, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Cholesterol, HDL, CO2, Creatine Kinase (CK), Creatinine, Gamma-Glutamyltransferase, Glucose, Iron, Lactate Dehydrogenase (LDH), Lipase, Magnesium, Phosphorous, Potassium, Sodium, T3 Uptake, T4 Total, Total Protein, Triglycerides, Iron-Binding Capacity, Unsaturated (UIBC), Uric Acid.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated with a specific number of samples. The determination of stability involves testing material over time, involving multiple aliquots and measurements.
Data Provenance: The studies were performed by Bio-Rad Laboratories. The country of origin of the data is not specified but is presumably the USA, where Bio-Rad Laboratories is located. The studies are prospective in nature, as they involve testing the product over its claimed stability periods (e.g., real-time shelf life studies).

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" typically refers to the expected values and acceptable ranges for analytes, which are established through extensive analytical testing and statistical analysis, not by expert interpretation in the same way a diagnostic imaging device would be. The "ground truth" for the analytes within the control is determined by the manufacturer's reference methods and value assignment processes.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, generally for diagnostic accuracy. This device's performance is determined through objective laboratory measurements and statistical analysis against pre-defined stability criteria.

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 a diagnostic device that would involve human readers or AI assistance in interpreting patient data.

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

Not applicable. This device is a physical reagent used to monitor the performance of analytical instruments. It does not employ an algorithm or AI.

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

The "ground truth" for this type of device is the expected concentration/activity of each analyte within the control material, along with established stability profiles. These are determined through:
- Reference analytical methods: Using highly accurate and precise analytical techniques to assign target values to the analytes in the control.
- Statistical analysis: To define the acceptable range of variation (precision) for each analyte over its claimed shelf life and open vial stability.
- Real-time stability studies: Monitoring the material's performance over its stated shelf life and open vial periods to confirm that analyte values remain within established acceptance limits.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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K03387

Page 1 of 2

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 (949) 598-1555 Fax:

Contact Person

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

Date of Summary Preparation

October 15, 2003

2.0 Device Identification

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

Classifications: Class I Product Code: JJY Requlation Number: CFR 862.1660

3.0 Device to Which Substantial Equivalence is Claimed

Bio-Rad Laboratories Liquid Assayed Multiqual Control Irvine, California Docket Number: K011867

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 manualtesting procedures.

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6.0 Comparison of the new device with the Predicate Device

Quest Diagnostics Serum Chemistry Control claims substantial equivalence to the Liquid Assayed Multiqual Control currently in commercial distribution (K011867).

	Quest DiagnosticsSerum Chemistry Control(New Device)	Bio-RadLiquid Assayed Multiqual Control(Predicate Device K011867)
Characteristics
Similarities
Intended Use	Quest Diagnostics Serum Chemistry Control isintended for use as a quality control serum tomonitor the precision of an individual laboratory'sautomated and manual-testing procedures.	Liquid Assayed Multiqual Control is intended for use asan assayed quality control serum to monitor theprecision of laboratory testing procedures for analyteslisted in this package insert.
Form	Liquid	Liquid
Matrix	Human serum based	Human serum based
Other ingredients	Stabilizers and preservatives	Stabilizers and preservatives
Differences
Storage(Unopened Frozen)	-10 °C to -20°CUntil expiration date	-20°C or colderUntil expiration date
Open Vial Claim	10 days at 2-8° C	14 days 2-8° C
Storage(Unopened Thawed)	No claim	30 days at 2-8° C
Analytes	Contains the following analytes that areequivalent to the predicate device:ALT; Albumin; Alkaline Phosphatase; Amylase;AST; Direct Bilirubin; Total Bilirubin; Blood UreaNitrogen; Calcium; Chloride; Cholesterol;Cholesterol, HDL; CO2; Creatine Kinase (CK);Creatinine; Gamma-Glutamyltransferase;Glucose; Iron; Lactate Dehydrogenase (LDH);Lipase; Magnesium; Phosphorous; Potassium;Sodium; T3 Uptake; T4 Total; Total Protein;Triglycerides; Iron-Binding Capacity,Unsaturated (UIBC); Uric Acid.	Contains the following additional analytes not claimedin the new product:Acetaminophen; Acid Phosphatase; Amikacin;Amylase, Pancreatic; Bilirubin, Neonatal; Calcium,ionized; Carbamazepine; Cholesterol, HDL;Cholesterol, LDL; CK-MB Isoenzyme; Cortisol; Digoxin;Ethyl Alcohol; Gentamicin; a-1-Antitripsin; HBDH;ApoA; ApoB; C3 Complement; C4 Complement;Ceruloplasmin; Cholinesterase; Copper; Ferritin;Globulin; Lithium; Osmolality; Phenobarbital;Phenytoin; Phospholipids; PAP; Salicylate; T3 Free; T3Uptake/T4 Uptake; T4 Free; Theophylline; TSH;Tobramycin; Valproic Acid; Haptoglobin; IgA ; IgG; IgM:TIBC; LAP Arylamidase; Prealbumin; ProteinElectrophoresis, Transferrin; Vitamin B12 Zinc.

	Table 1. Similarities and Differences between new and predicate device.

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:

7.1 Open vial: 10 days when stored tightly capped at 2-8°C.
7.2 Shelf Life: Two years when stored at -10 to -20 °C.
7.3 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.

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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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 2 2003

Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K033387

Trade/Device 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: October 15, 2003 Received: October 24, 2003

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 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 practicc requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): K033387

Device Name: Quest Diagnostics Serum Chemistry Control

Indications for Use:

ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ પ્રમુદ્

For use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use X or Over-the Counter use

Carol C Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K033387

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.