(22 days)
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No
The summary describes a quality control serum for laboratory testing, with no mention of AI or ML technologies.
No
The device is described as a quality control serum to monitor the precision of laboratory testing procedures, not for treating or diagnosing patients.
No
This device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a condition in a patient.
No
The device is a physical control serum, not a software application. It is a lyophilized product prepared from human serum with added constituents.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures for the analytes listed in the package insert." This is a classic function of a quality control material used in laboratory testing.
- Device Description: It's prepared from human serum with added constituents, which is a common matrix for IVD controls. It's also provided in lyophilized form, a typical presentation for stable IVD reagents.
- Intended User/Care Setting: The intended user is a "laboratory," which is where in vitro diagnostic testing is performed.
- Predicate Device: The presence of a predicate device (Lyphochek Immunoassay Plus Control) with a K number (K981532) strongly indicates that this device is being compared to a previously cleared IVD.
While it doesn't directly diagnose a disease, it is a critical component used in conjunction with IVD tests to ensure their accuracy and reliability. This falls squarely within the definition of an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
Quest Diagnostics Immunoassay/TDM Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Product codes
JJY
Device Description
Quest Diagnostics Immunoassay/TDM Control is prepared from human serum, with added constituents of human and animal origin, chemicals, and therapeutic drugs. The control is provided in lyophilized form for increased stability.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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 Immunoassay/TDM Control. Product claims are as follows:
- Open vial Stability: 7days when stored tightly capped at 2 to 8℃ with the following exceptions: ● C-Peptide, Folate and PSA are stable for 3 days and Gastrin, Free PSA and Intact PTH should be assayed immediately after reconstitution.
- . Shelf Life: 36 months when stored at 2 to 8 °C
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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MAR 2 4 2005
Bio-Rad Laboratories Premarket Notification Section 510(k) for Quest Diagnostics Immunoassay/TDM Control Summary of Safety and Effectiveness
Page 1 of 3
Ko 50536
Summary of Safety and Effectiveness Quest Diagnostics Immunoassay/TDM Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
February 24, 2005
2.0 Device Identification
Quest Diagnostics Immunoassay/TDM Control Product Trade Name: Multi-Analyte Controls, (Assayed and Unassayed) Common Name:
Classifications: Product Code: Requiation Number:
Class I JJY CFR 862.1660
Device to Which Substantial Equivalence is Claimed 3.0
Lyphochek Immunoassay Plus Control Bio-Rad Laboratories Irvine, CA 92618 Docket Number: K981532
4.0 Description of Device
Quest Diagnostics Immunoassay/TDM Control is prepared from human serum, with added constituents of human and animal origin, chemicals, and therapeutic drugs. The control is provided in lyophilized form for increased stability.
5.0 Statement of Intended Use
Quest Diagnostics ImmunoassayTDM Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
008_SSE_Quest_IA/TDM_930 2/05
1
6.0 Comparison of the new device with the Predicate Device
Quest Diagnostics Immunoassay/TDM Control claims substantial equivalence to the Lyphochek Immunoassay Plus Control currently in commercial distribution (K981532).
| Characteristics | Quest Diagnostics
Immunoassay/TDM Control
(New Device) | Bio-Rad Laboratories
Lyphochek Immunoassay Plus Control
(Predicate Device K981532) |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Quest Diagnostics Immunoassay/TDM Control is intended for use
as a quality control serum to monitor the precision of laboratory
testing procedures for the analytes listed in the package insert. | Lyphochek Immunoassay Plus Control is intended for use as an
assayed quality control serum to monitor the precision of
laboratory testing procedures for the analytes listed in the
package Insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human Serum | Human Serum |
| Preservatives | Does not Contains preservatives | Does not Contains preservatives |
| Storage (Unopened) | 2°C to 8°C
Until expiration date | 2°C to 8°C
Until expiration date |
| Differences | | |
| Reconstituted Vial
Claim | 7 days at 2 to 8°C
with the following exceptions:
(1) C-Peptide, Folate and PSA 3 days
(2) Gastrin, Free PSA and Intact PTH assay immediately | 7 days at 2°C to 8°C
with the following exceptions:
(1) Folate and PSA 3 days,
(2) C-Peptide 1 day,
(3) Intact PTH 16 hours,
(4) ACTH, Calcitonin, Gastrin and Free PSA assay immediately |
| After Reconstituting
and Freezing | No claims | All analytes 30 days at -10 to -20°C |
| Analytes | Contains the following analytes:
• 17-a-Hydroxyprogesterone
• Acetaminophen
• Aldosterone
• Alpha Fetoprotein (AFP)
• Amikacin
• Androstenedione
• Caffeine
• Carbamazepine
• CEA
• Chloramphenicol
• Cortisol
• C -Peptide
• DHEA Sulfate
• Digoxin
• Disopyramide
• Estradiol
• Estriol, Free
• Ethosuximide
• Ferritin
• Folate
• FSH
• Gastrin
• Gentamicin
• Homocysteine
• HCG
• HGH
• Immunoglobulin E (IgE) | Contains the following analytes:
• Lidocaine
• Lithium
• LH
• NAPA
• PTH, Intact
• Phenobarbital
• Phenytoin
• Primidone
• Procainamide
• Progesterone
• Prolactin
• PAP
• PSA
• PSA, Free
• Quinidine
• Salicylate
• T3, Free
• T3, Total
• T4, Free
• T4, Total
• Testosterone
• Theophylline
• Tobramycin
• TSH
• Valproic Acid
• Vancomycin
• Vitamin B12
• 11-Deoxycortisol
• 17-a-Hydroxyprogesterone
• Acetaminophen
• ACTH
• Alpha Fetoprotein (AFP)
• Amikacin
• Aldosterone
• Amitriptyline
• Androstenedione
• Caffeine
• Calcitonin
• Carbamazepine, Free
• Carbamazepine
• CEA
• Chloramphenicol
• Cortisol
• C-Peptide
• DHEA Sulfate
• Digoxin
• Disopyramide
• Cyclosporine
• Desipramine
• DHEA
• Estradiol
• Estriol, Free
• Estriol, Total
• Estrogens, Total
• Immunoglobulin E (IgE)
• Insulin
• Lidocaine
• Lithium
• LH
• NAPA
• Netilmicin
• Nortriptyline
• PTH
• Phenobarbital
• Phenytoin
• Phenytoin, Free
• Primidone
• Procainamide
• Progesterone
• Prolactin
• PAP
• Propanolol
• PSA
• PSA, Free
• Quinidine
• Salicylate
• T3 Free
• T3 Total
• T3 Uptake
• T4 Free
• T4 Total |
Table 1. Similarities and Differences between new and predicate device.
008_SSE_Quest_IA/TDM_930 2/05
2
Bio-Rad Laboratories Dio-Nab Laboratones
Premarket Notification Section 510(k) for Quest Diagnostics Immunoassay/TDM Control Summary of Safety and Effectiveness
| Characteristics | Quest Diagnostics
Immunoassay/TDM Control
(New Device) | | Bio-Rad Laboratories
Lyphochek Immunoassay Plus Control
(Predicate Device K981532) | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Does not Contain the following analytes:
• 11-Deoxycortisol
• Aldosterone
• Amitriptyline
• Calcitonin
• Carbamazepine, Free
• Cyclosporine *
• Desipramine
• DHEA
• Estriol, Total
• Estrogens, Total
• Flecainide
• 25-Hydroxy Vitamin D
• Angiotensin I
• Fructosamine
• Glucagon
• Iron
• TIBC | • HCG-Beta Subunit
• Imipramine
• Netilmicin
• Nortriptyline
• Phenytoin, Free
• Propanolol
• T3 Uptake
• TCA Screen
• Testosterone, Free
• Valproic Acid, Free
• Immunoglobulin A (IgA)
• Immunoglobulin G (IgG)
• Immunoglobulin M (IgM)
• Somatomedin-C
• TBG
• Thyroglobulin | • Folate
• Flecainide
• FSH
• Gastrin
• Gentamicin
• hCG and hCG-Beta Subunit
• hGH
• Imipramine
• 25-Hydroxy Vitamin D
• Angiotensin I
• Fructosamine
• Glucagon
• Iron
• TIBC
Does not Contain the following analytes:
• Homocysteine | • Testosterone, Free
• Theophylline
• Tobramycin
• TSH
• Valproic Acid
• Valproic Acid, Free
• Vancomycin
• Vitamin B12
• Immunoglobulin A (IgA)
• Immunoglobulin G (IgG)
• Immunoglobulin M (IgM)
• Somatomedin-C
• TBG
• Thyroglobulin |
1.0 STATEMENT OF SUPPORTING DATA
Stability studies have been performed to determine the open vial stability and shelf life for the Quest Diagnostics Immunoassay/TDM Control. Product claims are as follows:
- Open vial Stability: 7days when stored tightly capped at 2 to 8℃ with the following exceptions: ● C-Peptide, Folate and PSA are stable for 3 days and Gastrin, Free PSA and Intact PTH should be assayed immediately after reconstitution.
- . Shelf Life: 36 months when stored at 2 to 8 °C
All supporting data is retained on file at Bio-Rad Laboratories.
008_SSE_Quest_IA/TDM_930 2/05
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
MAR 2 4 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Manager/ Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
K050536 Re:
Trade/Device Name: Ouest Diagnostics Immunoassay/TDM Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 24, 2005 Received: March 2, 2005
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 practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Sincerely yours,
Jean M. Cooper MS, DVM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
CHClosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Quest Diagnostics Immunoassay/TDM Control
Indications For Use:
Quest Diagnostics Immunoassay/TDM 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)
Alute Sutt
(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number
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