(85 days)
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No
The document describes a quality control serum product and its stability studies, with no mention of AI or ML technology.
No.
The device is described as a quality control serum used to monitor the precision of laboratory testing procedures, not to treat or diagnose conditions directly.
No
Explanation: The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a disease or condition in a patient.
No
The device description explicitly states it is prepared from human serum and includes biochemical materials, chemicals, preservatives, and stabilizers, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring the precision of an individual laboratory's automated and manual-testing procedures" and "monitoring the precision of laboratory testing procedures for the analytes listed in this package insert." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific device is a control and not directly diagnosing a patient, it is an essential component of the in vitro diagnostic process, ensuring the accuracy and reliability of the tests being performed on patient samples.
- Device Description: The description mentions it's prepared from human serum and contains biochemical materials, chemicals, preservatives, and stabilizers. This is consistent with the composition of many IVD reagents and controls.
- Predicate Device: The mention of a predicate device (K033387; Bio-Rad Laboratories Quest Diagnostics Serum Chemistry Control) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
Therefore, based on the provided information, the Quest Diagnostics Serum Chemistry Control is 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 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.
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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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:
. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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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
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 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.
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 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 an individual laboratory's automated | ||||||
| and 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 Storage | ||||||
| Claim (Unopened) | -20°C to -70°C | |||||
| Until expiration date | -10°C to -20°C | |||||
| Until expiration date | ||||||
| Alternate Storage | ||||||
| Claim (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 Acid
Does 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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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
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Of In Vitro Diagnostic Device ation and Safety