(100 days)
Liquichek Immunoassay premium Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Liquichek immunoassay Premium Control is prepared from human serum with added constituents of human and animal origin, chemicals, therapeutic drugs, stabilizers and preservatives. The control is provided in liquid form for convenience.
The provided text is for a 510(k) premarket notification for a medical device called "Liquichek Immunoassay Premium Control." This device is a quality control material and as such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to the stability testing of the control material itself, rather than diagnostic accuracy or clinical effectiveness for patient diagnosis.
Here's the breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Thawed Opened Stability | Recovery result on final day (TFinal) being ± 10% of the recovery result of time zero vial (Tzero) | 14 days at 2 to 8°C (for most analytes) |
| Thawed Unopened Stability | Recovery result on final day (TFinal) being ± 10% of the recovery result of time zero vial (Tzero) | 28 days at 2 to 8°C (for most analytes) |
| Frozen Aliquot Stability | Recovery result on final day (TFinal) being ± 10% of the recovery result of time zero vial (Tzero) | 28 days at -20°C to -70°C |
| Shelf Life Stability* | Recovery result on final day (TFinal) being ± 10% of the recovery result of time zero vial (Tzero) | 28 Months at -20°C to -70°C (for most analytes) |
*Note: Real-time stability studies are ongoing to support the shelf life, implying that the 28-month claim is based on accelerated stability studies or early real-time data which met the criteria.
2. Sample size used for the test set and the data provenance
The document states that the mean values and ±3SD ranges for the control were derived from "replicate analyses," and that "Data from Unity™ Interlaboratory Program are included in the determination of some ranges." The stability studies involved testing the control at different time points (TFinal vs. Tzero).
- Sample Size (Test Set): Not explicitly stated as a single number. The term "replicate analyses" suggests multiple measurements were taken, but the exact number of replicates, samples, or lots tested for stability is not provided.
- Data Provenance: The studies were conducted by Bio-Rad Laboratories ("the manufacturer") and/or "independent laboratories using manufacturer supported reagents." The data would be prospective for the stability studies, as specific protocols would have been followed to test the device over time. The country of origin for the data is not specified, but Bio-Rad Laboratories is based in Irvine, California, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device. The "ground truth" for a quality control material like the Liquichek Immunoassay Premium Control is its known concentration of analytes and its stability over time. Ground truth is established through rigorous internal testing and value assignment processes, not expert consensus in the diagnostic sense, pathology, or outcomes data.
4. Adjudication method for the test set
Not applicable. As described above, this is a quality control material where the "ground truth" is measured analytical values, not expert interpretation requiring 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 does not involve human readers, AI, or diagnostic interpretation of cases. Its purpose is to monitor the precision of laboratory testing procedures performed by instruments.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical control material, not an algorithm or software. It is used in conjunction with laboratory instruments to ensure their accurate performance.
7. The type of ground truth used
The ground truth for this device is the assigned analyte concentrations (mean values) and expected stability performance over time. This is established through internal testing (replicate analyses by the manufacturer and/or independent laboratories) and comparison against specified acceptable ranges (e.g., ±10% recovery from Tzero).
8. The sample size for the training set
Not applicable. As a quality control material, there is no "training set" in the context of machine learning. The "value assignment" process involves establishing the target values and ranges for each analyte in a given lot of the control, which is an analytical characterization process.
9. How the ground truth for the training set was established
Not applicable, as there is no training set. The "value assignment" for the control material is done through "replicate analyses" by the manufacturer and/or independent laboratories, with "Data from Unity™ Interlaboratory Program" also included in some determinations. Each laboratory is then recommended to establish its own acceptable ranges, using the provided values as guides.
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K 132227
510(k) Summary
Liquichek Immunoassay Premium Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467
OCT 2 5 2013
Date of Summary Preparation
October 17, 2013
2.0 Device Identification
Product Trade Name: Liquichek Immunoassay Premium Control Common Name: Multi-Analyte Controls, All Kinds (Assayed) Classifications: Class I, Reserved Product Code: JJY Regulation Number: 21 CFR 862,1660
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek Immunoassay Plus Control Blo-Rad Laboratories Irvine, California
510 {k} Number: K001373
4.0 Description of Device
Liquichek immunoassay Premium Control is prepared from human serum with added constituents of human and animal origin, chemicals, therapeutic drugs, stabilizers and preservatives. The control is provided in liquid form for convenience.
Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitls B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product may also contain other human source material for which there are no approved tests.
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5.0 Value Assignment
The mean values and the corresponding ±3SD ranges printed In this Insert were derived from replicate analyses and are specific for this lot of product. Data from Unity™ Interlaboratory Program are included in the determination of some ranges. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, Instrumentation and reagents, or by manufacturer test method modifications.
6.0 Intended Use
Liquichek Immunoassay Premium Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
7.0 Comparison of the new device with the Predicate Device
Liquichek Immunoassay Premium Control claims substantial equivalence to the Liquichek Immunoassay Pius Control currently in commercial distribution (K001373). Table 1 (below) contains comparison Information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
| Characteristics | Liquichek Immunoassay Promium Control(New Device) | Liquichek Immunoassay Plus Control(Predicate Device, K001373) | ||
|---|---|---|---|---|
| Similarities | ||||
| Intended Use | Liquichek Immunoassay Premium Control Isintended for use as an assayed quality controlserum to monitor the precision of laboratory testingprocedures for the analytes listed in this packageinsert. | Liquichek Immunoassay Plus Control is Intendedfor use as an assayed quality control serum tomonitor the precision of laboratory testingprocedures for the analytes listed In this packageInsert. | ||
| Matrix | Human Serum | Human Serum | ||
| Form | Liquid | Liquid | ||
| Storage unopened(Shelf life) | -20°C to -70°C until expiration date | -20°C to -70°C until expiration date | ||
| Differences | ||||
| Fill Volume | Trilevel, Level 1, 2 and 3 – 6 x 5 mLTrilevel MiniPak - 3 x 5 mL | Level 1, 2 and 3– 12 x 5 mLTrilovol MiniPak - 3 x 5 mL | ||
| Thawed OpenedStability | 14 days at 2 to 8°C | 14 days at 2°C to 8 °C | ||
| Except | Folate: 4 days at 2 to 8°CEstradiol: 5 days at 2 to 8°CFree PSA: 7 days at 2 to 8°CVitamin D: 9 days at 2 to 8°CTotal PSA: 13 days at 2 to 8°C | Except | Folate: 4 days at 2 to 8°CEstradiol: 5 days at 2 to 8°C |
Table 1. Similarifies and Differences between new and predicate device.
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Bio-Rad Laboratories 510 (k) Summary
Lloulchek Immunoassay Premium Control
: : · :
.
| Thawed UnopenedStability | 28 days at 2 to 8°C | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Except | Folate: 4 days at 2 to 8°CEstradiol: 10 days at 2 to 8°CFree PSA & Prolactin: 16 days at 2 to 8°C | Except | 30 days at 2 to 8°CFolate: 4 days at 2 to 8°CEstradiol: 8 days at 2 to 8°CFree PSA, PSA, Prolactin: 14 days at2 to 8°C | |||||||
| Total PSA: 17 days at 2 to 8°C | ||||||||||
| Frozen aliquot | 28 days at -20 to -70 °C | |||||||||
| Analytes Include: Folate, Estradiol, Free PSA, Total PSA and Total Vitamin D | ||||||||||
| Analytes | Contains: | Contains: | ||||||||
| 25-Hydroxy Vitamin D | • | Phenytoin, FreePrimidoneProcainamideProgesteroneProlactinProstatic Specific Antigen, FreeProstate Specific Antigen, TotalQuinidineSalicylateT3 Uptake / T UptakeT3, FreeT3, TotalT4, FreeT4, TotalTricyclic Antidepressants ScreenTestosteroneTheophyllineTobramycinThyroid Stimulating HormoneThyroxine Binding GlobulinValproic AcidValproic Acid, FreeVancomycinVitamin B12Sex Hormone Binding GlobulinBeta-2-MicroglobulinCA 125CA 15-3CA 19-9 | 25-Hydroxy Vitamin DAcetaminophenAcid Phosphatase, Prostatic (PAP)Alpha FetoproteinAmikacinCaffeineCarbamazepineCarbamazepine, FreeCarcinoembryonic AntigenCortisolCyclosporineDigoxinDisopyramideDHEA-SulfateEstradiolEstriol, FreeEthosuximideFerritinFolateFollicle Stimulating Hormone (FSH)GentamicinhCG, Total betaHuman Growth HormoneImmunoglobulin AImmunoglobulin GImmunoglobulin EImmunoglobulin MInsulinLuteinizing HormoneLidocaineLithiumN-AcetylprocainamidePhenobarbitalPhenytoin | T3, TotalT4, FreeT4, TotalTricyclic Antidepressants ScreenTestosteroneTheophyllineTobramycinThyroid Stimulating HormoneThyroglobulinThyroxine Binding GlobulinValproic AcidValproic Acid, FreeVancomycinVitamin B12Sex Hormone Binding Globulin17-AlphaHydroxyprogesterone11-DeoxycortisolAldosteroneAmiodaroneAmitriptylineAndrostenedioneAngiotensin IAntithyroid Peroxidase AntibodiesAntithyroglobulin antibodyChloramphenicolCK-MB IsoenzymeDesipramineDehydroepiandrosteroneEstrogen, TotalEstriol, TotalFlecainideFructosamineHuman Chorionic Gonadotropin- Beta SubunitIbuprofenIronImipramineNetilmicinPropanololParathyroid Hormone - MMSomatomedin-CTestosterone, FreeTotal Iron Binding Capacity | ||||||
| Does not Contain: | Estriol, TotalFlecainideFructosamineHuman Chorionic Gonadotropin- Beta SubunitIbuprofenIronImipramineNetilmicinNortriptylinePropanololParathyroid Hormone - MMSomatomedin-CTestosterone, Free | |||||||||
| Desipramine Dehydroepiandrosterone Estrogen, Total | 17-AlphaHydroxyprogesterone11-DeoxycortisolAldosteroneAmiodaroneAmitriptylineAndrostenedioneAngiotensin IAntithyroid Peroxidase AntibodiesAntithyroglobulin antibodyCarbamazepine, FreeChloramphenicolCK-MB IsoenzymeCyclosporineDesipramine | Total Iron Binding Capacity Thyroglobulin | Does not Contain: Beta-2-Microglobulin CA 125 | CA 15-3 CA 19-9 |
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8.0 Statement of Supporting Data
Accelerated Stability studies have been performed to predict the Shelf life stability and real time studies were conducted to establish Thawed (opened and unopened) & Frozen aliquot claims for Liquichek Immunoassay Premium Control. Product claims are as follows:
| Thawed Opened Stability: | 14 days at 2 to 8°C (for most analytes) |
|---|---|
| Thawed Unopened Stability: | 28 days at 2 to 8°C (for most analytes) |
| Frozen Aliquot | 28 days at -20°C to -70°C |
| Shelf Life Stability: | 28 Months at -20°C to -70°C (for most analytes) |
The acceptance criteria for above studies is defined as the recovery result on final day (TFInal) being ± 10% of the recovery result of time zero vial (Tzero).
Real-time stability studies are ongoing to support the shelf life of this product.
9.0 Conclusion
Based on the performance characteristics indicated above, Liquichek immunoassay Premium Control is substantially equivalent to the predicate device (K001373).
All supporting data is retained on file at Bio-Rad Laboratories.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2013
BIO-RAD LABORATORIES c/o Ms. Suzanne Parsons 9500 Jeronimo Rd. IRVINE CA 92618-2017
Re: K132227
Trade/Device Name: Liquichek Immunoassay Premium Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: September 25, 2013 Received: September 26, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Ms. Parsons
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincercly yours.
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K132227
Device Name: Liquichek Immunoassay premium Control
Indication for Use:
Liquichek Immunoassay premium Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Prescription Use V And/Or (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung VF Dan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K132227
§ 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.