(28 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 a quality control serum for monitoring the precision of laboratory testing procedures, not for treating specific medical conditions.
No
The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a disease or condition in a patient.
No
The device is a liquid control material, 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." This is a key characteristic of IVD devices, which are used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific control doesn't directly diagnose a patient, it's an essential component of the diagnostic process by ensuring the accuracy of the tests being performed.
- Device Description: The description mentions it's prepared from "human serum" and used in "laboratory testing procedures." This aligns with the definition of an IVD, which involves testing biological samples in a laboratory setting.
- Intended User / Care Setting: The intended user is "laboratory testing procedures," further reinforcing its use within a clinical laboratory environment.
- Predicate Device: The mention of a predicate device (K981532; Lyphochek Immunoassay Plus Control) which is also a quality control material for immunoassay testing, strongly suggests that this device falls under the same regulatory category as its predicate, which are typically classified as IVDs.
While the document doesn't contain information about image processing, AI/ML, or patient-specific details, the core function and context of the device clearly place it within the realm of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Liquichek Specialty Immunoassay Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for analyte listed in the package insert.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Liquichek Specialty Immunoassay Control is prepared from human serum with added constituents of human and animal origin, chemicals, stabilizers, and preservatives. This provided in liquid form.
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 Specialty Immunoassay Control. Product claims are as follows:
Open vial: 30 days at 2°C to 8°C with the following exceptions: Anti-Tg and Anti-TPO will be stable for 21 days
Shelf Life Stability: 2 Years at -20 to -70°C
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.
0
Summary of Safety and Effectiveness Liquichek Spacialty Immunoassay Control
1.0 Submitter
DEC - 7 2004
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:
Contact Person
Suzanne Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
November 2, 2004
2.0 Device Identification
| Product Trade Name: | Liquichek Specialty Immunoassay Control |
|---|---|
| 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
Lyphochek Immunoassay Plus Control Bio-Rad Laboratories Irvine, California
510 (k) Number: K981532
4.0 Description of Device
Liquichek Specialty Immunoassay Control is prepared from human serum with added constituents of human and animal origin, chemicals, stabilizers, and preservatives. This provided in liquid form.
5.0 Intended Use
Liquichek Specialty Immunoassay Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for analyte listed in the package insert.
1
6.0 Comparison of the new device with the Predicate Device
Liquichek Specialty Immunoassay Control claims substantial equivalence to the Lyphochek Immunoassay Plus Control currently in commercial distribution (K981532). Both products are serum based products that contain muliple analytes used to monitor precision of laboratory testing procedures.
| Characteristics | Bio-Rad Laboratories
Bio-Rad Liquichek Specialty Immunoassay Control
(New Device) | Bio-Rad Laboratories
Lyphochek Immunoassay PlusControl
(Predicate Device K981532) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Specialty Immunoassay Control is intended for use as
quality control serum to monitor the precision of laboratory testing
procedures listed in the package insert. | Lyphochek Immunoassay Plus Control is intended for use as
quality control serum to monitor the precision of laboratory testing
procedures listed in the package insert |
| Stabilizers | Contains Stabilizers | Contains Stabilizers |
| Matrix | Human Serum | Human Serum |
| Differences | | |
| Form | Liquid | Lyophilized |
| Preservatives | Contains Preservatives | None |
| Storage
(Unopened) | -20 to -70°C
Until expiration date | 2 to 8°C
Until expiration date |
| Open Vial | 30 days at 2-8°C with the following exceptions: Anti-Tg and Anti-
TPO will be stable for 21 days | 7 days at 2 to 8 °C with the following exceptions: (1) Folate and
PSA will be stable for 3 days after reconstitution, (2) C-Peptide
will be stable for 1 day, (3) Intact PTH will be stable for 16 hours
after reconstitution, and (4) ACTH, Calcitonin, Gastrin and Free
PSA should be assayed immediately after reconstitution. |
| Alternate storage | None | After reconstituting and freezing: all analytes will be stable for 20
at -10 to -20°C with the following exceptions: no frozen stability
claim is supplied for ACTH, Aldosterone, Androstenedione,
Calcitonin and C-Peptide. |
| Analytes | Contains only the following analytes:
• Anti-Tg
• Anti-TPO
• C-peptide
• Erythropoietin (EPO)
• Intact PTH (iPTH)
• IGF-I
• Osteocalcin
• 25-OH Vitamin D | Contains the following analytes:
Multi anlyte including:
• 25-OH Vitamin D
• C-peptide
• Intact PTH (iPTH)
Does not contain:
• Anti-Tg
• Anti-TPO
• Erythropoietin (EPO)
• IGF-I
• Osteocalcin |
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 Specialty Immunoassay Control. Product claims are as follows:
| 7.1 | Open vial | 30 days at 2°C to 8°C with the following exceptions: Anti-
Tg and Anti-TPO will be stable for 21 days |
|-----|----------------------|----------------------------------------------------------------------------------------------------------|
| 7.2 | Shelf Life Stability | 2 Years at -20 to -70°C |
All supporting data is retained on file at Bio-Rad Laboratories.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is rendered in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 7 2004
Ms. Suzanne S. Parsons Regulatory Affairs Specialist Bio-Rad Laboratories. Inc. 9500 Jeronimo Rd. Irvine, CA 92618-2017
Re: K043108
Trade/Device Name: Liquichek Specialty Immunoassay Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJY Dated: November 4, 2004 Received: November 9, 2004
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.
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 legally
3
Page 2 – Ms. Suzanne S. Parsons
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-3084. 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,
Lala M. Beattie/
Robert L. Becker, Jr., M.B., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K043108 |
|---|---|
| Device Name: | Liquichek Specialty Immunoassay Control |
| Indications For Use: | Liquichek Specialty Immunoassay Control is intended for use as a |
| quality control serum to monitor the precision of laboratory testing | |
| procedures listed in the package insert. |
× Prescription Use_ (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)
Mana Clan
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K043108