(23 days)
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No
The document describes a quality control serum for laboratory testing and does not mention any AI or ML components in its description, intended use, or performance studies.
No.
The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to treat or diagnose a medical condition.
No
Explanation: The device is described as an "assayed quality control serum to monitor the precision of laboratory testing procedures," not to diagnose a disease or condition in a patient.
No
The device is a physical control serum used in laboratory testing, not a software application.
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 in vitro diagnostic control material.
- Device Description: It's a "quality control serum" prepared from biological material (human plasma) and used in laboratory testing.
- Care Setting: It's intended for use in "laboratory testing procedures."
These characteristics align with the definition of an In Vitro Diagnostic device, 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 a test itself, it is an essential component used with IVD tests to ensure their accuracy and reliability.
N/A
Intended Use / Indications for Use
Liquichek Immunology Control 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.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Liquichek Immunology Control is prepared from defibrinated human plasma with added serum proteins, preservatives and stabilizers. The control is provided in liquid form for convenience. Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.
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)
Real-time stability studies were conducted to establish the thawed stability claims (opened and unopened). Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance Criteria were met to support the product claims as follows:
Thawed and Opened: 5 days at 2 to 8°C
Thawed and Unopened: 10 days at 2 to 8°C
Shelf Life Stability: 2 Years at -20 to -50°C
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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510(k) Summary Liquichek Immunology Control
Submitter
APR 1 2 2013
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467
Date of Summary Preparation
March 6, 2013
1.0 Submission Number
2.0 Device Identification
Product Trade Name: | Liquichek Immunology Control |
---|---|
Common Name: | Multi-Analyte Controls, All Kinds (Assayed) |
Review Panel: | Clinical Chemistry and Clinical Toxicology Devices |
Classifications: | Class I, Reserved |
Product Code: | JJY |
Regulation Number: | 21 CFR 862.1660 |
3.0 Intended Use
Liquichek Immunology Control 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.
4.0 Device to Which Substantial Equivalence is Claimed
Liquichek Immunology Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K022991
5.0 Description of Device
Liquichek Immunology Control is prepared from defibrinated human plasma with added serum proteins, preservatives and stabilizers. The control is provided in liquid form for convenience.
Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.
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Table 1: Product Configuration | |||
---|---|---|---|
-- | -- | -- | -------------------------------- |
Level | Configuration |
---|---|
Level 1 | 6 x 2.5 mL |
Level 2 | 6 x 2.5 mL |
Level 3 | 6 x 2.5 mL |
Trilevel MiniPak | 3 x 2.5 (1 per level) mL |
Comparison of the new device with the Predicate Device 6.0
The new Liquichek Immunology Control claims substantial equivalence to the Liquichek Immunology Control currently in commercial distribution (K022991). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
Table 2: Similarities and Differences between the new and predicate device
| Characteristics | Liquichek Immunology Control
(New Device) | Liquichek Immunology Control
(Predicate Device, K022991) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Immunology Control 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. | Liquichek Immunology Control 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. |
| Matrix | Defibrinated Human Serum | Defibrinated Human Serum |
| Form | Liquid | Liquid |
| Analytes | Contains:
Albumin Alpha-1-Acid Glycoprotein Alpha-1-Antitrypsin Alpha-2-Macroglobulin Antistreptolysin O Apolipoprotein A-1 Apolipoprotein B Beta-2-Microglobulin C1 Inhibitor C-Reactive Protein (CRP) Ceruloplasmin Complement C3 Complement C4 Cystatin C Ferritin Haptoglobin IgG1 Subclass IgG2 Subclass IgG3 Subclass IgG4 Subclass Immunoglobulin A Immunoglobulin E Immunoglobulin G Immunoglobulin M Kappa Light Chain Lambda Light Chain Prealbumin Protein, Total | Contains:
Albumin Alpha-1-Acid Glycoprotein Alpha-1-Antitrypsin Alpha-2-Macroglobulin Antistreptolysin O Apolipoprotein A-1 Apolipoprotein B Beta-2-Microglobulin C1 Inhibitor C-Reactive Protein (CRP) Ceruloplasmin Complement C3 Complement C4 Cystatin C Ferritin Haptoglobin IgG1 Subclass IgG2 Subclass IgG3 Subclass IgG4 Subclass Immunoglobulin A Immunoglobulin E Immunoglobulin G Immunoglobulin M Kappa Light Chain Lambda Light Chain Prealbumin Protein, Total |
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Bio-Rad Laboratories 510(k) Summary Liquichek Immunology Control
Rheumatoid FactorTransferrin | Rheumatoid FactorTransferrin | |
---|---|---|
Differences | ||
Fill Volume | 2.5 mL | 1mL & 3 mL |
Thawed Opened | ||
Stability | 5 days at 2 to 8°C | 30 days at 2 - 8 °C Except for: |
Beta-2-Microglobulin: 21 days at 2 to 8°C | ||
Rheumatoid Factor: 5 days at 2 to 8°C | ||
Thawed Unopened | ||
Stability | 10 days at 2 to 8°C | 90 days at 2 to 8°C Except for: |
Rheumatoid Factor: 25 days at 2 to 8°C | ||
Storage unopened | ||
(Shelf life) | -20°C to -50°C until expiration date | -20°C to -70°C until expiration date |
Analytes | Does not Contain: | |
Anti-deoxyribonuclease BAntithrombin IIICH50 (Total hemolytic Complement)Lipoprotein (a)HemopexinProperdin Factor BSoluble Transferrin Receptor (sTfR) |
7.0 Value Assignment
The mean values and the corresponding ±3SD ranges printed in the instructions for use were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.
8.0 Statement of Supporting Data
Real-time stability studies were conducted to establish the thawed stability claims (opened and unopened). Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance Criteria were met to support the product claims as follows:
Thawed and Opened: | 5 days at 2 to 8°C |
---|---|
Thawed and Unopened: | 10 days at 2 to 8°C |
Shelf Life Stability: | 2 Years at -20 to -50°C |
9.0 Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
10.0 Conclusion
Based on the performance characteristics indicated above, the Bio-Rad Liquichek Immunology Control is substantially equivalent to the predicate device K022991.
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 and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2013
Bio-Rad Laboratories c/o Ms. Suzanne Parsons 9500 Jeronimo Road IRVINE CA 92618-2017
Re: K130761
Trade/Device Name: Liquicheck Immunology Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I Product Code: JJY Dated: March 13, 2013 Received: March 20, 2013
Dear Ms. Parsons:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
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Page 2-Ms. Suzanne Parsons
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Maria M. Chan -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known):__k130761
Device Name:
Liquichek Immunology Control
Indications for Use:
Liquichek Immunology Control 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 (21 CFR Part 801 Subpart D) C)
Over the Counter Use (21 CFR Part 801 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Maria M. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)_k130761