(27 days)
Liquichek TDM Is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes fisted in the package insert.
Liquichek™ TDM is prepared from human serum, with added constituents of nonhuman protein, drugs and preservatives. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information for the Liquichek™ TDM 1, 2, 3 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Once thawed and opened, all analytes stable for 30 days when stored tightly capped at 2-8°C. Exceptions: T3 total and T3 free stable for 15 days; Diazepam stable for 24 hours. | "Once the control is thawed and opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C, with the following exceptions: Ta total and T3 free will be stable for 15 days and Diazepam will be stable for 24 hours days. Avoid repeated freezing and thawing of the quality control material." (Matches criteria) |
| Closed Vial Stability | When thawed and stored unopened at 2-8°C, all analytes stable for 180 days. Exceptions: Cortisol, Desipramine, T4 total and T3 free stable for 30 days. | "When the control material is thawed and stored unopened at 2-8° C all analytes will be stable for 180 days with the following exceptions: Cortisol, Desipramine, and T4 total and T3 free are stable for 30 days." (Matches criteria) |
| Shelf Life | 36 months when stored at -20°C or colder. | "Shelf Life: 36 months when stored at -20 °C or colder." (Matches criteria) |
| Substantial Equivalence | The new device (Liquichek™ TDM 1, 2, 3 with preservatives) should be substantially equivalent to the predicate device (Liquichek™ TDM 1, 2, 3 without preservatives) in terms of intended use, form, matrix, storage conditions (unopened frozen), analytes, storage (unopened thawed), and open vial claims, with the addition of preservatives. | The submission claims "substantial equivalence to the Liquichek™...in commercial distribution (K893682)." The comparison table explicitly shows that the "new device" (with preservatives) has the same intended use, form, matrix, storage (unopened frozen) and analytes as the "predicate device." Minor differences in specific analyte stability within the "unopened thawed" and "open vial claim" categories are noted, but these are addressed by the specific stability study findings. The FDA concludes with a "substantial equivalence determination." (Meets the implicit substantial equivalence criteria based on the provided comparison and FDA letter). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size (number of control vials, number of tests conducted) used for the stability studies. It broadly refers to "stability studies" and "real time studies."
- Data Provenance: The studies were conducted by Bio-Rad Laboratories. The data is retained "on file at Bio-Rad Laboratories" in Irvine, California, USA. This indicates the data is likely retrospective but performed by the manufacturer. Specific country of origin for all data points (e.g., if external labs were used for any validation) is not detailed beyond Bio-Rad's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device and study. The Liquichek™ TDM 1, 2, 3 is a quality control material. Its "ground truth" (i.e., its established analyte concentration and stability) is determined through analytical laboratory testing using established reference methods, not by expert consensus or interpretation of images/data by human experts. The performance data relates to the intrinsic stability of the chemical components within the control material, not human diagnostic accuracy.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation or diagnosis is involved and there's a need to resolve disagreements among experts. This is an analytical chemistry/device stability study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with/without AI
This is not applicable. This device is a quality control material, not an AI-powered diagnostic tool. Therefore, there are no "human readers," "AI assistance," or MRMC studies involved.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. This is a laboratory control material, not an algorithm or software device.
7. The Type of Ground Truth Used
The "ground truth" for this device, which is a quality control material, is established by analytical laboratory measurements using reference methods for the various analytes. The stability studies evaluate whether the measured concentrations of these analytes remain within acceptable limits over time and under various storage conditions. The specific reference methods are not detailed in this summary but would be part of Bio-Rad's internal documentation.
8. The Sample Size for the Training Set
This is not applicable. As a quality control material, there is no "training set" in the context of machine learning or AI. The product's characteristics are developed through chemical formulation, manufacturing processes, and validated through stability testing.
9. How the Ground Truth for the Training Set Was Established
This is not applicable due to the absence of a training set. The "ground truth" for the product's performance (i.e., stability and assay values) is established through rigorous analytical testing and adherence to manufacturing specifications.
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Summary of Safety and Effectiveness Liquichek™ TDM 1, 2, 3
K0127411
/12/01
Submitter 1.0
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist (949) 598-1367 Telephone:
Date of Summary Preparation
August 15, 2001
Device Identification 2.0
| Product Name: | Liquichek™ TDM 1, 2, 3 |
|---|---|
| --------------- | ------------------------ |
Drug Mixture Control Materials Common Name:
Dif
Classifications:
Class |
Product Code:
Regulation Number:
21 CFR 862.3280
Device to Which Substantial Equivalence is Claimed 3.0
Original 510(k) Name: Kit Ciba Corning L-TDM Control I, III Current Name: Liquichek™ TDM 1, 2, 3 Bio-Rad Laboratories Irvine, California
Docket Number: K893682
Description of Device 4.0
Liquichek™ TDM is prepared from human serum, with added constituents of nonhuman protein, drugs and preservatives. The control is provided in liquid form for convenience.
5.0 Statement of Intended Use
Liquichek™ TDM is intended for use as an assayed quality control serum to monitor the precision of laboratory procedures and other analytes listed in the package insert.
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Comparison of the new device with the Predicate Device 6.0
The new Liquichek™ TDM 1, 2, 3 claims substantial equivalence to the Liquichek™ The now Liquicher in commercial distribution (K893682). The new Liquichek™ TDM 1, 2, 3 contains preservatives and the current product does not.
| Characteristics | Bio RadLiquichekTM TDM 1, 2, 3(New Device) | Bio RadLiquichekTM TDM 1, 2, 3(Predicate Device) |
|---|---|---|
| Intended Use | Liquichek TDM 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 TDM 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. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Storage(Unopened Frozen) | -20°C or colderuntil expiration date | -20°C or colderuntil expiration date |
| Analytes | Same as Predicate (see insert) | Same as new device (see insert) |
| Storage(Unopened Thawed) | 2-8° C for 180 daysExceptions:Cortisol, Desipramine, T4 total and T3 free are stable for 30 days. | 2-8° C for 180 daysExceptions:Clonazepam, Cortisol, Desipramine, and free T4 are stable for 30 days. |
| Open Vial Claim | 2-8° C for 30 days.Exceptions:T3 total and T3 free will be stable for 15 days andDiazepam will be stable for 24 hours days. | 2-8° C for 30 days.Exceptions:T3 will be stable for 15 days andDiazepam will be stable for 24 hours days. |
| Preservatives | Preservatives are added | No preservatives or stabilizers were added |
Table 1. Similarities and Differences between new and predicate device.
SUMMARY OF PERFORMANCE DATA 7.0
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ TDM 1, 2, 3. Product claims are as follows:
- 7.1 Open vial: Once the control is thawed and opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C, with the following exceptions: Ta total and T3 free will be stable for 15 days and Diazepam will be stable for 24 hours days.
Avoid repeated freezing and thawing of the quality control material.
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- Closed Vial: When the control material is thawed and stored unopened at 2-8° C 7.2 all analytes will be stable for 180 days with the following exceptions: Cortisol, Desipramine, and T4 total and T3 free are stable for 30 days
- Shelf Life: 36 months when stored at -20 °C or colder 7.3
Real time studies to support the shelf life of this product are available.
All supporting data is retained on file at Bio-Rad Laboratories.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.
SEP 1 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618
K012741 Re: ·
Trade/Device Name: Liquichek™ TDM 1, 2, 3 Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: Class I, reserved Product Code: DIF Dated: August 15, 2001 Received: August 16, 2001
Dear Ms. Platt:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becatermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surve in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 2018 11:07 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.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2
510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Device Name: Liquichek™ TDM 1, 2, 3
Indications for Use:
Liquichek TDM Is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes fisted in the package insert.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription use | or | Over-the Counter use | |
|---|---|---|---|
| ------------------ | ---------------------------------------------------------------------- | ---- | ---------------------- |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K012741 |
|---|---|
| --------------- | --------- |
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.