(42 days)
Not Found
No
The document describes a quality control serum for laboratory testing, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a quality control serum used to monitor the precision of laboratory testing procedures, not to treat or cure a disease.
No
Explanation: The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a patient's condition.
No
The device is a quality control serum, which is a physical substance 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 B-type Natriuretic Peptide (BNP)." This is a classic function of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: It's a "quality control serum" prepared from human serum with added constituents. This is a common form for IVD control materials.
- Intended User / Care Setting: It's used in "laboratory testing procedures," which is the typical setting for IVDs.
While it doesn't directly diagnose a disease, it's a crucial component in ensuring the accuracy and reliability of diagnostic tests (in this case, BNP tests), which falls under the scope of IVDs.
N/A
Intended Use / Indications for Use
Liquichek BNP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for B-type Natriuretic Peptide (BNP).
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
Liquichek BNP Control is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is 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
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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™ BNP Control. Product claims are as follows:
- 2.1 Open vial: All analytes will be stable for 20 days at 2 to 8℃.
- 2.2 Shelf Life: 2 years at -20°C to -70°C
- 2.3 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.
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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FEB - 8 2005
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Suzanne S. Parsons Requlatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
December 21, 2004
2.0 Device Identification
| Product Trade Name: | Liquichek BNP Control |
|---|---|
| Common Name: | Single (Specific) Analyte Controls, (Assayed and Unassayed) |
| Classifications: | Class I |
| Product Code: | JJX |
| Regulation Number: | CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Cardiac Markers Control LT Bio-Rad Laboratories Irvine, California
Docket Number: K040277
4.0 Description of Device
Liquichek BNP Control is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form.
5.0 Statement of Intended Use
- 6.0 Liquichek BNP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the B-type Natriuretic Peptide (BNP).
The Liquichek BNP Control does not contain sodium azide as a preservative. It contains a broadspectrum anti-microbial cocktail as a preservative where the concentration of any one ingredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.
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7.0 Comparison of the new device with the Predicate Device
Liquichek BNP Control claims substantial equivalence to the Liquichek™ Cardiac Markers Control LT currently in commercial distribution. The new Liquichek BNP Control is a 3 level product (Level 1, 2, and 3) and contains only BNP. The current product is a multi-analyte product and does not contain BNP.
| Characteristics | Bio-Rad
Liquichek™ BNP Control
(New Device) | Bio-Rad
Liquichek™ Cardiac Markers Control LT
(Predicate Device K040277) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek BNP Control is intended for use as a quality control
serum to monitor the precision of laboratory testing procedures
B-type Natriuretic Peptide (BNP). | Liquichek Cardiac Markers Control LT is intended for use as
an assayed quality control serum to monitor the precision of
laboratory testing procedures listed in the package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Differences | | |
| Storage
(Unopened) | -20°C to -70°C
Until expiration date | -20°C or colder
Until expiration date |
| Open Vial Claim | 20 days at 2-8°C | All analytes 10 days, NT-proBNP 4 days at 2-8°C |
| Analytes | Contains:
B-type Natriuretic Peptide (BNP)
Does not contain:
CK-MB Isoenzyme
Digitoxin
Homocysteine
Myoglobin
N-terminal pro-B-type Natriuretic Peptide (NT-pro BNP)
Troponin I
Troponin T | Contains:
CK-MB isoenzyme
Digitoxin
Homocysteine
Myoglobin
N-terminal pro-B-type Natriuretic Peptide (NT-pro BNP)
Troponin I
Troponin T
Does not contain
B-type Natriuretic Peptide (BNP) |
Table 1. Similarities and Differences between new and predicate device.
2.0 STATEMENT OF SUPPORTING DATA
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ BNP Control. Product claims are as follows:
- 2.1 Open vial: All analytes will be stable for 20 days at 2 to 8℃.
- 2.2 Shelf Life: 2 years at -20°C to -70°C
- 2.3 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three horizontal lines that curve and converge, resembling a human figure or a bird in flight.
FEB - 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Suzanne S. Parsons Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K043584
Trade/Device Name: Liquichek BNP Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: December 21, 2004 Received: December 28, 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 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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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 (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,
Jean M. Cooper MS, DUM
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
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Liquichek BNP Control
Indications For Use:
Liquichek BNP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for B-type Natriuretic Peptide (BNP).
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)
Page 1 of
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K043584