(50 days)
Not Found
No
The document describes a quality control serum for laboratory testing and does not mention any AI or ML components.
No
The device is described as an "unassayed quality control serum" used to "monitor precision of IgM laboratory testing procedures." It is not intended for diagnosis or treatment, but rather for quality control in laboratory settings, which is not a therapeutic use.
No
Explanation: This device is described as an "unassayed quality control serum" intended to "monitor precision of IgM laboratory testing procedures," not to diagnose a patient's condition. It contains known quantities of analytes to verify the proper functioning of diagnostic tests, rather than providing a diagnosis itself.
No
The device is a quality control serum, which is a biological material used in laboratory testing, not a software application.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring precision of IgM laboratory testing procedures for the analytes listed". This indicates it's used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- Device Description: It's a "quality control serum" used in laboratory testing.
- Analytes: The listed analytes (CMV, EBV, HSV, Lyme, Rubella, Toxoplasma) are all targets of diagnostic tests for infectious diseases.
- Predicate Device: The predicate devices listed (VIROCLEAR ToRCH & VIROCLEAR ToRCH -M) are also likely IVDs, further supporting the classification of this device.
While it's a quality control material and not a test that directly diagnoses a patient, it is an essential component used within the process of in vitro diagnostic testing to ensure the accuracy and reliability of those tests. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays.
Analytes Listed in the package insert:
- Cytomegalovirus (CMV) IgM
- Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA) IgM
- Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM
- Lyme (Borrelia burgdorferi) IgM
- Rubella Virus IgM
- Toxoplasma gondii IgM
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Liquichek ToRCH Plus IgM Control, Positive is prepared from negative human serum based material with mouse IgM monoclonal antibodies conjugated to non-specific human IgM molecules for each analyte tested. The positive control reagent also contains constituents of animal origin and preservatives. The following are the specificities of each monoclonal antibody:
Analyte Cytomegalovirus (CMV) Epstein-Barr Virus EBV (VCA) gp125 Herpes Simplex Virus Type 1 (HSV-1) gC1 Herpes Simplex Virus Type 2 (HSV-2) gG2 Lyme (Borrelia burgdorferi) Rubella Virus E1 Toxoplasma gondii p30
IgM Monoclonal antibody specificity p52, pp65, and gB OspA and OspB
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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 Liquichek™ ToRCH Plus IgM Control. Product claims are as follows:
- Open vial: All analytes will be stable for 60 days when stored at 2 to 8°C.
- Shelf Life: 3 Years at -20°C or colder
- Real time studies will be ongoing to support the shelf life of this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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 MAY 1 9 2004 Liquichek ToRCH Plus IgM 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 Requlatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
March 26, 2004
2.0 Device Identification
| Product Trade Name: | Liquichek ToRCH Plus IgM Control |
|---|---|
| Common Name: | Multi-analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
VIROCLEAR ToRCH & VIROCLEAR ToRCH -M Blackhawk BioSystems, Inc. San Ramon, California
510 (k) Number: K942295
4.0 Description of Device
Liquichek ToRCH Plus IgM Control, Positive is prepared from negative human serum based material with mouse IgM monoclonal antibodies conjugated to non-specific human IgM molecules for each analyte tested. The positive control reagent also contains constituents of animal origin and preservatives. The following are the specificities of each monoclonal antibody:
Analyte Cytomegalovirus (CMV) Epstein-Barr Virus EBV (VCA) gp125 Herpes Simplex Virus Type 1 (HSV-1) gC1 Herpes Simplex Virus Type 2 (HSV-2) gG2 Lyme (Borrelia burgdorferi) Rubella Virus E1 Toxoplasma gondii p30
IgM Monoclonal antibody specificity p52, pp65, and gB OspA and OspB
08_510(k) Torch IgM_ 229_ 04/04
1
5.0 Intended Use
Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays.
Comparison of the new device with the Predicate Device 6.0
Liguichek ToRCH Plus IgM Controls claim substantial equivalency to the VIROCLEAR ToRCH and VIROCLEAR ToRCH-M Controls currently in commercial distribution (K942295).
| Bio-Rad | Blackhawk BioSystems, Inc. | |
|---|---|---|
| Characteristics | Liquichek™ ToRCH Plus IgM Control | |
| (New Device) | VIROCLEAR ToRCH Control | |
| (Predicate Device K942295) | ||
| Similarities | ||
| Intended Use | Liquichek ToRCH Plus IgM Control is intended for use as an | |
| unassayed quality control serum to monitor precision of IgM | ||
| laboratory testing procedures for the analytes listed in this | ||
| package insert. This product is not intended for use in blood | ||
| donor screening assays. | VIROCLEAR ToRCH / VIROCLEAR ToRCH-M: is intended | |
| for use as an unassayed precision quality reagent with in | ||
| vitro assay procedure for determination of IgG and IgM | ||
| antibodies to TOXO, Rubella virus CMV and HSV (1 & 2) | ||
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Preservatives | Contains preservatives | Contains preservatives |
| Open Vial Claim | 60 days at 2 to 8°C | 60 days at 2°C to 8°C |
| Number of Levels | Reactive (positive) and Non-reactive (negative) | Reactive and Non-reactive |
| Differences | ||
| Storage (Unopened) | -20°C or colder | |
| Until expiration date | 2°C – 8°C | |
| Until expiration date | ||
| Analytes | IgM antibodies to: | |
| Cytomegalovirus (CMV) | ||
| Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA) | ||
| Herpes Simplex Virus Type 1/2 (HSV-1/2) | ||
| Lyme (Borrelia burgdorferi) | ||
| Rubella Virus | ||
| Toxoplasma gondii | ||
| It does not test for antibodies to IgG | IgM and IgG antibodies to: | |
| Cytomegalovirus (CMV) | ||
| Herpes Simplex Virus Type 1/2 (HSV-1/2) | ||
| Rubella Virus | ||
| Toxoplasma gondii | ||
| It does not test for antibodies to: |
- Lyme (Borrelia burgdorferi)
- Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA) |
Table 1. Similarities and Differences between new and predicate device.
7.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ ToRCH Plus IgM Control. Product claims are as follows:
- 7.1 Open vial: All analytes will be stable for 60 days when stored at 2 to 8°C.
- 7.2 Shelf Life: 3 Years at -20°C or colder
- 7.3 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 9 2004
Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, CA 92618-2017
K040822 Re:
Trade/Device Name: Liquichek™ ToRCH Plus IgM Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJY Dated: March 26, 2004 Received: March 30, 2004
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 mcan 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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Page 2
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Saqarts
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices 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): | K040822 |
|---|---|
| Device Name: | Liquichek ToRCH Plus IgM Control |
| Indications For Use: | Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. |
Analytes Listed in the package insert:
- Cytomegalovirus (CMV) IgM
- Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA) IgM
- Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM
- Lyme (Borrelia burgdorferi) IgM
- Rubella Virus IgM
- Toxoplasma gondii IgM
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)
Vagaxh
Division Sign-Off
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Saffety
510(k) _ KO40827