(42 days)
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).
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.
This document describes a 510(k) premarket notification for the "Liquichek BNP Control" device. The acceptance criteria and supporting studies are focused on the device's stability and its intended use as a quality control serum for monitoring the precision of laboratory testing procedures for B-type Natriuretic Peptide (BNP).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Open Vial Stability: | |
| All analytes stable for 20 days at 2 to 8°C | All analytes are stable for 20 days at 2 to 8°C. |
| Shelf Life Stability: | |
| 2 years at -20°C to -70°C | The product has a shelf life of 2 years at -20°C to -70°C. |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of clinical or diagnostic performance evaluation with patient samples. The studies discussed are related to the intrinsic stability of the control material itself. Therefore, sample sizes for a traditional test set or its provenance (country, retrospective/prospective) are not applicable or provided in this regulatory document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a quality control material, not a diagnostic device that requires expert-established ground truth from patient data. The "ground truth" for this product relates to its stability and consistency over time, which is determined through laboratory testing of the control material itself.
4. Adjudication method for the test set
Not applicable. As noted above, this is a quality control material, not a diagnostic device evaluated with patient samples requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a quality control material and is not an AI-powered diagnostic tool, nor does it involve human readers interpreting results in the context of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical quality control serum, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this quality control device, the "ground truth" for the stability studies would be defined by the expected stable concentration of BNP over time, under specified storage conditions. This is established through internal scientific methods and validated analytical procedures by the manufacturer (Bio-Rad Laboratories) using reference methods or internal standards to measure BNP concentration in the control material at various time points.
8. The sample size for the training set
Not applicable. This device is a manufactured control material undergoing stability testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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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-RadLiquichek™ BNP Control(New Device) | Bio-RadLiquichek™ Cardiac Markers Control LT(Predicate Device K040277) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek BNP Control is intended for use as a quality controlserum to monitor the precision of laboratory testing proceduresB-type Natriuretic Peptide (BNP). | Liquichek Cardiac Markers Control LT is intended for use asan assayed quality control serum to monitor the precision oflaboratory testing procedures listed in the package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Differences | ||
| Storage(Unopened) | -20°C to -70°CUntil expiration date | -20°C or colderUntil 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 IsoenzymeDigitoxinHomocysteineMyoglobinN-terminal pro-B-type Natriuretic Peptide (NT-pro BNP)Troponin ITroponin T | Contains:CK-MB isoenzymeDigitoxinHomocysteineMyoglobinN-terminal pro-B-type Natriuretic Peptide (NT-pro BNP)Troponin ITroponin TDoes not containB-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.
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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)
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K043584
§ 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.