(49 days)
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No
The document describes a quality control serum and its stability, with no mention of AI or ML technologies.
No
The device is described as an assayed quality control serum to monitor the precision of laboratory testing procedures, not for treating or diagnosing patients.
No
Explanation: This device is described as an "assayed quality control serum" used to "monitor the precision of laboratory testing procedures." It is not directly used to diagnose a patient's condition or disease, but rather to ensure the accuracy of tests performed for diagnostic purposes.
No
The device description explicitly states it is prepared from human serum and includes biochemical material, chemicals, drugs, preservatives, and stabilizers, 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 "monitoring the precision of laboratory testing procedures for the analytes listed in this package insert." This is a classic function of an IVD, specifically a quality control material used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: It's prepared from human serum and contains added biochemical materials, chemicals, drugs, preservatives, and stabilizers. This composition is typical of a control material used in laboratory testing.
- Intended User / Care Setting: It's intended for use in "laboratory testing procedures," which is the environment where IVDs are used.
While the document doesn't explicitly use the term "IVD," the intended use and description clearly align with the definition of an in vitro diagnostic device. It's a reagent or material used to verify the performance of other diagnostic tests performed on biological samples.
N/A
Intended Use / Indications for Use
Liquid Assayed Multiqual 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.
Product codes
JJY
Device Description
Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, 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
Stability studies have been performed to determine the open vial stability and shelf life for the Liquid Assayed Multiqual. Product claims are as follows:
Open vial: 14 days at 2 to 8°C, with the following exception: LAP Arylamidase will be stable for 3 days.
Thawed and Unopened: 30 days at 2 to 8°C, with the following exceptions: Total Bilirubin values may decrease, Alkaline Phosphatase activity may rise. The control must be stored frozen when using AST methods without pyridoxal-5-phosphate.
Shelf Life Stability: 3 Years at -20°C or colder
All supporting data is retained on file at Bio-Rad Laboratories.
Key Metrics
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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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Summary of Safety and Effectiveness Liquid Assayed Multiqual
JAN - 7 2005
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
November 16, 2004
2.0 Device Identification
| Product Trade Name: | Liquid Assayed Multiqual |
|---|---|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquid Assayed Multiqual Bio-Rad Laboratories Irvine, California
510 (k) Number: K011867
4.0 Description of Device
Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.
. . . . . . . . . .
5.0 Intended Use
Liquid Assayed Multiqual 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.
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Comparison of the new device with the Predicate Device 6.0
Liquid Assayed Multiqual claims substantial equivalence to the Liquid Assayed Multiqual currently in commercial distribution (K011867). Both of these are liquid, human serum based controls. The new Liquid Assayed Multiqual contains the same analytes as the predicate device with the addition of Lactic Acid.
| Characteristics | Bio-Rad Laboratories
Liquid Assayed Multiqual Control
(New Device) | | Bio-Rad Laboratories
Liquid Assayed Multiqual Control
(Predicate Device K011867) | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Similarities | | | |
| Intended Use | Liquid Assayed Multiqual is intended for use as an assayed
quality control serum to monitor the precision of laboratory
testing procedures for the analytes listed in this package insert. | | Liquid Assayed Multiqual is intended for use as an assayed
quality control serum to monitor the precision of laboratory
testing procedures for the analytes listed in this package insert. | |
| Form | Liquid | | Liquid | |
| Matrix | Human serum based | | Human serum based | |
| Storage (Unopened) | -20°C or colder Until expiration date | | -20°C or colder Until expiration date | |
| Open Vial Claim | 14 days at 2 to 8°C, with the following exception: LAP
Arylamidase will be stable for 3 days. | | 14 days at 2 to 8°C, with the following exception: LAP
Arylamidase will be stable for 3 days. | |
| | Differences | | | |
| Analytes | Contains: | | Contains:
Same analytes as the new device with the exception of Lactic Acid. | |
| | Acetaminophen
Alpha-1-Antitripsin
αHBDH
Apolipoprotein A-1
Apolipoprotein B
Alkaline Phosphatase (ALP)
ALT/SGPT
Amikacin
Amylase
Amylase, Pancreatic
AST/SGOT
Acid Phosphatase
Albumin
Bilirubin, Direct
Bilirubin, Neonatal
Bilirubin, Total
C3 Complement
C4 Complement
Ceruloplasmin
Cholinesterase
Calcium, Ionized
Copper
Calcium, Total
Carbamazepine
Carbon Dioxide (CO2)
Chloride
HDL
LDL
Cholesterol, Total
CK-MB Isoenzyme
Cortisol
Creatinine
Creatine Kinase (CK)
Ferritin
Ethanol
Digoxin
GGT
Gentamicin
Globulin
Glucose | Iron
Immunoglobulin A (IgA)
Immunoglobulin G (IgG)
Immunoglobulin M (IgM)
TIBC
UIBC
Lactate (Lactic Acid)
LDH
LAP Arylamidase
Lipase
Lithium
Magnesium
Osmolality
Phenobarbital
Phenytoin
Phospholipids
Phosphorus
Potassium
Prealbumin
PAP
Protein Electrophoresis
Protein, Total
Salicylate
Sodium
T3 Free
T3 Total
T3 Uptake/T-Uptake
T4 Total
T4 Free
Theophylline
TSH
Tobramycin
Transferrin
Triglycerides
Urea
Urea Nitrogen (BUN)
Uric Acid
Valproic Acid
Vitamin B12
Zinc | | |
Table 1. Similarities and Differences between new and predicate device.
:
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Statement of Supporting Data 7.0
Stability studies have been performed to determine the open vial stability and shelf life for the Liquid Assayed Multiqual. Product claims are as follows:
| 7.1 | Open vial | 14 days at 2 to 8°C, with the following exception: LAP Arylamidase will be stable for 3 days. |
|---|---|---|
| 7.2 | Thawed and Unopened: | 30 days at 2 to 8°C, with the following exceptions: Total Bilirubin values may decrease, Alkaline Phosphatase activity may rise. The control must be stored frozen when using AST methods without pyridoxal-5-phosphate. |
| 7.3 | Shelf Life Stability | 3 Years at -20°C or colder |
・・・・・
All supporting data is retained on file at Bio-Rad Laboratories.
・・・・・・
・・・・・
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird's head and neck. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 7 2005
Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K043208
Trade/Device Name: Liquid Assayed Multiqual Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: November 16, 2004 Received: November 19, 2004
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) rms lotet notification. The FDA finding of substantial equivalence of your device to a legally preshand nedicate 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)276-0484. 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/industry/support/index.html
Sincerely yours,
Carelia B. Looks
Cornelia B. Rooks, MA Acting 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):
510(k) Number (if known): K043208
Device Name:
Liquid Assayed Multiqual
Indications For Use:
Liquid Assayed Multiqual is intended for use as an assayed 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)
Division Sign-Off
acting
Office of In Vitro Diagnostic Device Evaluation and S
510(k) KD43208
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