(40 days)
Not Found
No
The summary describes a quality control serum with no mention of AI/ML technology or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as a "quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures," not for treating a condition or disease.
No
This device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a patient's medical condition. It helps ensure the accuracy of diagnostic tests but is not a diagnostic device itself.
No
The device description clearly states it is a serum chemistry control prepared from human serum and other biological/chemical components, indicating it is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "For use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures." This clearly indicates it's used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- Device Description: The description mentions it's prepared from human serum and contains biochemical materials, chemicals, preservatives, and stabilizers. These are components typically found in IVD reagents and controls.
- Predicate Device: The mention of a predicate device (K011867; Bio-Rad Laboratories Liquid Assayed Multiqual Control) which is also a quality control material, further supports its classification as an IVD. Predicate devices are used in the regulatory process for IVDs.
While the document doesn't mention image processing, AI, DNN, or ML, and lacks detailed performance study results beyond stability, the core function and intended use align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JJY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
an individual laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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.
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 Diagnostics
Serum Chemistry Control
(New Device) | Bio-Rad
Liquid Assayed Multiqual Control
(Predicate Device K011867) |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | | |
| Similarities | | |
| 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. | Liquid Assayed Multiqual Control is intended for use as
an assayed quality control serum to monitor the
precision of laboratory testing procedures for analytes
listed 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°C
Until expiration date | -20°C or colder
Until 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 are
equivalent to the predicate device:
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. | Contains the following additional analytes not claimed
in 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; T3
Uptake/T4 Uptake; T4 Free; Theophylline; TSH;
Tobramycin; Valproic Acid; Haptoglobin; IgA ; IgG; IgM:
TIBC; LAP Arylamidase; Prealbumin; Protein
Electrophoresis, 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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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 (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
4
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