Who is the manufacturer of QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL?

Bio-Rad filed the 510(k) submission for QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL (K050536).

What is the FDA product code for QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL?

JJY. It is classified under 21 CFR 862.1660 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL?

510(k) clearance (submission type: Traditional).

What are the predicate devices for QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL?

Lyphochek Immunoassay Plus Control (K981532).

Who can help prepare an FDA 510(k) submission like QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL

K050536 · Bio-Rad · JJY · Mar 24, 2005 · Clinical Chemistry

Device Facts

Record ID	K050536
Device Name	QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
Applicant	Bio-Rad
Product Code	JJY · Clinical Chemistry
Decision Date	Mar 24, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1660
Device Class	Class 1

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.

Device Story

Quest Diagnostics Immunoassay/TDM Control is a quality control serum prepared from human serum, supplemented with human/animal-derived constituents, chemicals, and therapeutic drugs. Provided in lyophilized form for stability, it is used by laboratory personnel to monitor the precision of immunoassay and therapeutic drug monitoring (TDM) testing procedures. The control is reconstituted and analyzed alongside patient samples; healthcare providers compare the measured values of the control against expected ranges to verify the accuracy and precision of the laboratory's analytical systems. This monitoring ensures the reliability of clinical test results, supporting informed clinical decision-making and patient safety.

Clinical Evidence

Bench testing only. Stability studies were conducted to validate open-vial stability (7 days at 2-8°C, with specific exceptions) and shelf life (36 months at 2-8°C). No clinical data was required or provided.

Technological Characteristics

Lyophilized human serum matrix; contains added human/animal-derived constituents, chemicals, and therapeutic drugs. No preservatives. Storage at 2°C to 8°C. Standalone quality control material; no software or electronic components.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for specific analytes in clinical settings.

Regulatory Classification

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.

Predicate Devices

Lyphochek Immunoassay Plus Control (K981532)

Related Devices

K973894 — IMMUSURE · Quantimetrix Corp. · Oct 29, 1997
K971060 — PRECINORM TDM CONTROLS · Boehringer Mannheim Corp. · Jul 7, 1997
K981532 — LYPHOCHEK IMMUNOASSAY PLUS CONTROL · Bio-Rad · May 12, 1998
K122838 — LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK · Bio-Rad Laboratories · Oct 17, 2012
K020237 — IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 · Consolidated Technology · Mar 19, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ # 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). {4}------------------------------------------------ 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 > ----------------- Page 1 of