(8 days)
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No
The document describes a linearity verifier for in vitro diagnostic methods, focusing on chemical properties and performance testing on existing systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is an in vitro diagnostic (IVD) medical device used to verify the calibration and linearity of methods for measuring therapeutic drugs, not for directly treating or diagnosing patients.
No
This device is intended to verify the calibration and linearity of methods used to determine drug concentrations, not to diagnose diseases or conditions in patients. It is a control material for laboratory instruments.
No
The device description explicitly states that ABC Linearity Verifiers is an "in vitro diagnostic medical device" and a "five level set of verifiers... made with human serum". This indicates a physical, biological component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used to verify the calibration, linear operating range and reportable range (linearity) of methods used to determine the concentration of selected therapeutic drugs." This is a classic function of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The "Device Description" section further clarifies that it is an "in vitro diagnostic medical device intended for use with automated and manual methods monitoring selected therapeutic drugs (TDM)." It also describes the composition (human serum) and how it is used in the laboratory setting to assess the performance of TDM methods.
- Regulatory Context: The mention of the Clinical Laboratory Improvement Act (CLIA) and its regulations regarding linearity and calibration verification reinforces that this type of product falls under the purview of regulations governing clinical laboratory testing, which is where IVDs are used.
Therefore, based on the provided text, the ABC Linearity Verifiers clearly fit the definition and intended use of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ABC Linearity Verifiers is intended to be used to verify the calibration, linear operating range and reportable range (linearity) of methods used to determine the concentration of selected therapeutic drugs.
ABC Linearity Verifiers should be used any time it is necessary to confirm the proper calibration ind linear operating range of TDM methods and instruments. The Clinical Laboratory Improvenent Act and its regulations (CLIA) require verification of timearity and calibration twice a year for modified moderately complex methods, highly complex methods and in-house methods. Verification should be performed more often if any of the following occurs: introduction of procedures for which control values change with a new reagent lot, major preventative maintenance or replacement of critical parts on the instrument, when control values exhibit an unusual trend or shift or are outside the acceptable limits of the laboratory, and if the laboratory's schedule of verification is more frequent.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
ABC Linearity Verifiers is an in vitro diagnostic medical device intended for use with automated and manual methods monitoring selected therapeutic drugs (TDM). ABC Linearity Verifiers is a five level set of verifiers, with each level containing 12 analytes, is made with human serum and is used to confirm the proper callbration, linear operating range and reportable range (linearity) of TDM methods. The "ABC" designation derives from Antibiotic and Cardiac drugs. ABC Linearity Verifiers contains concentrations of analytes extending over a wide analytical range. Level 1 is a zero level, and level 5 has concentrations near the upper limit of instruments. Levels 1, 2, 3, and 4 are related by linear dilution. When assayed like patient samples, the verifiers assist in determination of calibration and linear operating range (linearity) of methods for the analytes included.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
The performance of ABC Verifiers has been tested on two commonly used automated therapeutic drug monitoring systems (Abbott TDx Assay System and Behring (formerly Syva) EMIT system reagents) and by HPLC methods for selected analytes to validate their use. All methods tested demonstrated the desired functionality of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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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SC Calibrators & Controls LLC, 1701 Berkeley Street, Santa Monica CA 90404 Tel: (310) 828-7423 Fax: (310) 453-1666
Image /page/0/Picture/1 description: The image shows a black and white photograph of a person's face. The person's face is partially obscured by a white circle in the upper left corner of the image. The person's facial features are not clearly visible, but it appears that they have a light complexion. The background of the image is black.
OCT 1 4 1997
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Contact Name: Rov F. Schall, Jr., Ph.D.
Date: August 31. 1997
Product Name: ABCtm Linearity Verifiers
Common Names:Calibration Verifiers, Linearity Verifiers
Document TDM | Linearity Set. Casco Standards. Inc. Predicate Devices: LiniCAL Protein I Calibration Verifiers, International Enzymes, Inc.
ABC Linearity Verifiers is an in vitro diagnostic med-Description of the Device: ical device intended for use with automated and manual methods monitoring selected therapeutic drugs (TDM). ABC Linearity Verifiers is a five level set of verifiers, with each level containing 12 analytes, is made with human serum and is used to confirm the proper callbration, linear operating range and reportable range (linearity) of TDM methods. The "ABC" designation derives from Antibiotic and Cardiac drugs. ABC Linearity Verifiers contains concentrations of analytes extending over a wide analytical range. Level 1 is a zero level, and level 5 has concentrations near the upper limit of instruments. Levels 1, 2, 3, and 4 are related by linear dilution. When assayed like patient samples, the verifiers assist in determination of calibration and linear operating range (linearity) of methods for the analytes included. (A second product, ABC Calibration Verifiers, is identical in every respect to this product except that the concentrations of levels 2, 3, and 4 aretargeted to regions of clinical interest. Both products will perform linear range and calibration verification, and their composition, stabilities and performance are identical except for concentration of middle levels.)
ABC Linearity Verifiers is intended to be used to verify the calibra-Intended Use: tion, linear operating range and reportable range (linearity) of methods used to determine the concentration of selected therapeutic drugs.
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Technical Characteristics Compared to Predicate Devices:
Comparison of Features of ABC Linearity Verifiers and the two predicate devices: DOCUMENT TDM I Linearity Test Set and LiniCAL Protein I Callbration Verifiers.
| Attribute | ABC Linearity Verifiers | DOCUMENT TDM I | LiniCAL Protein I |
|---|---|---|---|
| No Analytes/bottle | 12 | 19 | 6 |
| No of Levels/set | 5 | 8 | 5 |
| Vol per level (mL) | 5 | 5 | 1 |
| Type of Analytes | Therapeutic Drugs | Therapeutic Drugs | Serum Proteins |
| Method(s) | Automated, Manual | ||
| Immunoassay, other | Automated | ||
| Immunoassay | Beckman Array | ||
| Nephelometer | |||
| Base Matrix | Human Serum | Human Serum | Human Serum |
| Preservative | Non-Azide | Azide | Azide |
| Calibration | Gravimetric + Some | ||
| Traceable | Assayed | ||
| (Two Methods) | Assayed + Traceable | ||
| Use | Verification of Calibration, | ||
| Linear Operating Range (OR), | |||
| Reportable Range | |||
| All Methods | Verif. of Calib, | ||
| Linear OR, | |||
| Reportable | |||
| Range for | |||
| Two Methods | Verif. of Calib, | ||
| Linear OR | |||
| Beckman Array | |||
| Stablilty | 60 days at 2-8° C; | To Expiration | To Expiration Date |
| To Expir. Date if frozen | at 2-8° C | unopened at 2-8°C | |
| (Vancomycin 30 days 2-8°C) | 14 days opened |
Technical Characteristics by Assessment of Performance: The performance of ABC Verifiers has been tested on two commonly used automated therapeutic drug monitoring systems (Abbott TDx Assay System and Behring (formerly Syva) EMIT system reagents) and by HPLC methods for selected analytes to validate their use. All methods tested demonstrated the desired functionality of the product.
Based upon the purpose of the device, the descriptions and label-Conclusions: ing of the predicate devices, and upon the safety and efficacy using multiple instruments and methods, and stability data generated for the ABC Verifiers, the product is substantially equivalent to the predicate devices.
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Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. In the center of the logo is a stylized symbol that resembles an abstract caduceus or a person embracing another, with flowing lines representing movement or connection.
OCT 14 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SC Calibrators & Controls LLC Ms. Carole Stamp c/o TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891
Re : K973790 Trade Name: ABC™ Linearity Verifiers Requlatory Class: I Product Code: JJY September 19, 1997 Dated: Received: October 6, 1997
Dear Ms. Stamp:
We have reviewed your Section 510(k) notification of intent wo market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Stamp
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655 .
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 requlation (21 CFR Part 801 and 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its internet address
"http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Toutman
Steven I. Gutman, M.D. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT 12.0
The Office of Device Evaluation (ODE) has developed the attached optional form to assist them with instituting the requirement for all original 510(k)s received by ODE on or after 1/2/96.
The requirement is for all 510(k) submissions to have clearly defined "Indications for Use". These indications will be attached by ODE to any substantial equivalence (SE) letter to define what the device is cleared for.
No 510(k) submitted on or after 1/2/96 will be cleared for marketing by ODE without the inclusion of the indications for use information, which will be attached to an SE letter.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ___________
Linearity Verifiers Device Name: _A B C ""
Indications For Use:
Indications For Use
ABC Linearity Verifiers should be used any time it is necessary to confirm the proper calibration ind linear operating range of TDM methods and instruments. The Clinical Laboratory Improvenent Act and its regulations (CLIA) require verification of timearity and calibration twice a year for modified moderately complex methods, highly complex methods and in-house methods. Verification should be performed more often if any of the following occurs: introduction of procedures for which control values change with a new reagent lot, major preventative maintenance or replacement of critical parts on the instrument, when control values exhibit an unusual trend or shift or are outside the acceptable limits of the laboratory, and if the laboratory's schedule of verification is more frequent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IN NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K973790 |
OR Over-The-Counter Use
Description Use
(Per 21 CFR 801.109)(Optional Format 1-2-96)