(14 days)
Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This control is substantially equivalent to the following quality control material that is currently in the market: Lyphochek Tumor Markers Control Bio-Rad Laboratories Irvine, California 92618 510 (k) Number: K011579. The new device is in liquid form with a matrix of human and animal serum albumin, contains preservatives, has Level 1, 2 and 3, and has different storage and open vial claims compared to the predicate device. It also contains claims for a different set of analytes.
This document is a 510(k) premarket notification for the Bio-Rad Laboratories Liquichek Tumor Markers Control. The purpose of a 510(k) is to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described here are focused on establishing substantial equivalence rather than traditional performance metrics like sensitivity, specificity, or AUC as might be seen for a diagnostic or AI device.
1. A table of acceptance criteria and the reported device performance
The core "acceptance criteria" for a 510(k) in this context is demonstrating substantial equivalence to a predicate device. This is achieved by comparing characteristics and showing that any differences do not raise new questions of safety or effectiveness. The "reported device performance" primarily refers to stability studies supporting the product claims.
| Acceptance Criteria (Demonstrates Substantial Equivalence) | Reported Device Performance (Supporting Substantial Equivalence) |
|---|---|
| Intended Use: Match the predicate device's intended use. | Both the Liquichek Tumor Markers Control (new device) and Lyphochek Tumor Markers Control (predicate) are intended as assayed quality control materials to monitor the precision of laboratory testing procedures for listed analytes. |
| Similarities: Identify key characteristics that are the same as the predicate. | Similarities stated: Identical intended use. |
| Differences: Identify differences from the predicate and provide data or justifications that these differences do not raise new safety or effectiveness concerns. | Differences identified: - Form: Liquid (new) vs. Lyophilized (predicate) - Matrix: Human and animal serum albumin (new) vs. Human serum (predicate) - Levels: Level 1, 2, and 3 (new) vs. Level 1 and 2 (predicate) - Preservatives: Contains preservatives (new) vs. Does not contain preservatives (predicate) - Storage (Unopened): -20°C to -70°C, until expiration date (new) vs. 2°C to 8°C, until expiration date (predicate) - Open Vial Claim / After reconstitution: All analytes 30 days at 2-8°C (exception: IGF-1 15 days) (new) vs. All analytes 14 days at 2-8°C (various exceptions) (predicate) - After reconstituting and freezing: No claims (new) vs. 30 days at -10 to -20°C (predicate) - Analytes: Some differences in the specific list of claimed analytes (new device contains claims for some analytes not in predicate and vice versa). |
| Stability: Support claims for shelf life and open vial stability with relevant studies. | Stability Studies Performed: - Open Vial Stability: All analytes stable for 30 days at 2-8℃, except IGF-1 (15 days). - Shelf Life: 2 Years at -20°C to -70°C. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document is for a quality control material and does not involve a "test set" in the sense of clinical samples for a diagnostic or AI device. The "study" mentioned refers to stability studies of the control material itself.
- Sample size for stability studies: Not explicitly stated in this summary. It mentions "Stability studies have been performed," implying internal testing of the control material batches.
- Data provenance: Not explicitly stated, but it's internal Bio-Rad Laboratories data. Given the address, it's likely originating from Irvine, California, USA.
- Retrospective or prospective: Stability studies are inherently prospective, following the material over time under defined conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a quality control material, not a diagnostic device requiring expert interpretation of clinical data to establish a ground truth. The "ground truth" for a QC material is its established analyte concentrations and stability profiles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical test set requiring adjudication in this submission.
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 is a quality control material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a quality control material, the "ground truth" is established through:
- Assigned Values/Target Concentrations: These are determined by the manufacturer through rigorous analytical testing using reference methods and/or highly characterized calibrators.
- Stability Profiles: Determined by real-time and accelerated stability studies under various storage and usage conditions, measuring changes in analyte concentrations over time.
8. The sample size for the training set
Not applicable. This is a quality control material, not an AI device trained on a dataset.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/algorithm is involved.
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Bio-Rad Laboratories Liquichek Tumor Markers Control Premarket Notification Section 510(k)
1.0 DEVICE INFORMATION
| Product Name: | Liquichek Tumor Markers Control |
|---|---|
| Common Name: | Clinical Chemistry Test SystemsQuality control material (assayed and unassayed) |
2.0 MEDICAL DEVICE ESTABLISHMENT
| Manufacturing Facility: | Bio-Rad Laboratories |
|---|---|
| Address: | 9500 Jeronimo RoadIrvine, California 92618 |
| Telephone: | 949-598-1200 |
| Fax: | 949-598-1557 |
Establishment Registration No .: 2016706
3.0 DEVICE CLASS
| Classification: | Class I |
|---|---|
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
4.0 PERFORMANCE STANDARDS
None Require
5.0 PROPOSED LABELING
Included in this 510(k) notification is a copy of the proposed Liquichek Tumor Markers Control vial, box and insert labels (Appendices 3, 4 and 5).
6.0 Statement of Substantial Equivalence
Liquichek Turnor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This control is substantially equivalent to the following quality control material that is currently in the market:
Lyphochek Tumor Markers Control Bio-Rad Laboratories Irvine, California 92618
510 (k) Number: K011579
A copy of the product insert for the above product can be found in Appendix 7.
JUL 3 1 2007
02_510(k) Liq Tumor Markers_547 07/07 - Rev. 7/25/07
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Comparison of the new device with the Predicate Device 7.0
Liquichek Tumor Markers Control claims substantial equivalence to the Lyphochek Tumor Markers Control currently in commercial distribution (K011579).
| Table 1. Similarities and Differences between new and predicate device. | ||
|---|---|---|
| Characteristics | Bio-Rad LaboratoriesLiquichek Tumor Markers Control(New Device) | Bio-Rad LaboratoriesLyphochek Tumor Markers Control(Predicate Device (K011579) |
| Similarities | ||
| Intended Use | Liquichek Tumor Markers Control is intended for use as anassayed quality control material to monitor the precision oflaboratory testing procedures for the analytes listed in thepackage insert. | Lyphochek Tumor Markers Control is intended for use as anassayed quality control material to monitor the precision oflaboratory testing procedures for the analytes listed in the packageinsert. |
| Differences | ||
| Form | Liquid | Lyophilized |
| Matrix | Human and animal serum albumin | Human serum |
| Levels | Level 1, 2 and 3 | Level 1 and 2 |
| Preservatives | Contains preservatives | Does not contains preservatives |
| Storage (Unopened) | -20°C to -70°C.Until expiration date | 2°C to 8°CUntil expiration date |
| Open Vial Claim /After reconstitution | All analytes 30 days at 2 to 8°C,Exceptions:• Insulin-like Growth Factor-I (IGF-1) 15 days. | All analytes 14 days at 2 to 8°CExceptions:• Ferritin and CA 27-29 6 days.• ACTH, Free PSA, PSA, Calcitonin assay immediately. |
| After reconstitutingand freezing | No claims | 30 days at -10 to -20°C. |
| Analytes | Contains claim for the following:• Alpha Fetoprotein• Beta-2-Microglobulin• CA 15-3• CA 19-9• CA 27.29• CA 125• CEA• Ferritin• hCG (β-hCG, Total hCG, Intact hCG)Does not contain claim for the following:• Aldosterone• ACTH• CA 50• CASA• Neuron Specific Enolase | Contains claim for the following:• Alpha Fetoprotein• Beta-2-Microglobulin• CA 15-3• CA 19-9• CA 27-29• CA 72-4• CA 125• CEA• CYFRA 21-1• Ferritin• hCG hCG – Beta SubunitDoes not contain claim for the following:• Thyroglobulin• Insulin-like Growth Factor-I |
Table 1. Similarities and Differences between new and predicate device
Statement of Supporting Data 8.0
Stability studies have been performed to determine the open vial stability and shelf life for this control. Product claims are as follows:
- Open vial Stability: All analytes will be stable for 30 days at 2 to 8℃, with the . following exception: Insulin-like Growth Factor-I (IGF-1) will be stable for 15 days.
- . Shelf Life: 2 Years at -20°C to -70°C
All supporting data is retained on file at Bio-Rad Laboratories.
CONFIDENTIAL
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Attachment 2
Liquichek Tumor Markers Control Summary of Safety and Effectiveness
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bio-Rad Laboratories c/o Ms. Maria Zeballos Regulatory Affairs Specialist 9500 Jeronimo Rd. Irvine, CA 92618-2017
JUL 3 1 2007
Re: K071675
Trade/Device Name: Liquichek Tumor Markers Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 15, 2007 Received: June 19, 2007
Dear Ms. Zeballos:
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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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Page 2 –
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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Robert M. Beckerf
Robert L. Becker, Jr., M.D., Ph.D Director Division of Immunology and Hematology 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):
Ko71675
Device Name:
Liquichek Tumor Markers Control
Indications For Use:
Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes 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)
Maria Inchan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of
510k)
§ 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.