(14 days)
VITROS Free T3 Reagent Pack For in vitro diagnostic use only. The VITROS Free T3 Reagent Pack quantitatively measures free triodothyronine (FT3) concentration in serum and plasma (EDTA or heparin) to aid in the differential diagnosis of thyroid disease.
VITROS Free T3 Calibrators - For in virro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Free T3 in serum and plasma (EDTA or heparin)
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Free T3 Reagent Pack, VITROS Immunodiagnostic Products Free T3 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Free T3 assay.
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided text describes a 510(k) submission for a new formulation of the VITROS Immunodiagnostic Products Free T3 Reagent Pack and Free T3 Calibrators. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device.
Here's an analysis of the acceptance criteria and the study as described, specifically addressing the points requested and noting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., specific thresholds for accuracy, precision, correlation). Instead, it relies on demonstrating "substantial equivalence" to a predicate device. The study's reported performance is a comparison of characteristics and the overall conclusion of equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (New Formulation) |
|---|---|
| Substantial Equivalence to Predicate Device | Concluded as substantially equivalent. |
| Sample Type Compatibility | Serum and plasma (EDTA or heparin). |
| Antibody Type | One sheep polyclonal anti-T3 antibody in conjugate reagent. Immunogen: T3-edestin. Source: Purchased from a supplier. |
| Calibration Range | 0-35 pmol/L. |
| Basic Principle | Solid phase immunoassay. |
| Tracer | Enzyme labeled. |
| Instrumentation | VITROS Immunodiagnostic System. |
| Sample Volume | 25µL. |
| Incubation Time & Temperature | 16 minutes at 37°C with shaking. |
| Performance with Patient Samples | Equivalence demonstrated using patient samples with measured Free T3 values spanning the assay range. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Equivalence was demonstrated using manufactured reagents along with patient samples with measured Free T3 values spanning the assay range." However, the specific sample size used for the test set is not provided.
The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated. It can be inferred that the samples are human given the intended use "in human body fluids."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable or discussed for in vitro diagnostic (IVD) assays, particularly those measuring analytes like Free T3. The "ground truth" for an IVD device is typically established by laboratory reference methods or comparison to a predicate device's established values, not by human expert interpretation of images or clinical assessments in the same way as an AI-powered diagnostic imaging tool. Therefore, this information is not present in the document.
4. Adjudication Method for the Test Set
As explained in point 3, the concept of expert adjudication in the context of diagnostic performance for an assay like Free T3 is not typically relevant. The comparison is based on quantitative measurements. Therefore, no adjudication method is described or applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation where human readers are involved. For an automated in vitro diagnostic assay, an MRMC study is not applicable.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
This device is an in vitro diagnostic assay, which by its nature operates "standalone" in the sense that it performs a chemical analysis to produce a quantitative result without direct human interpretation of the underlying signal in the way an imaging algorithm does. The "algorithm" here is the chemical reaction and detection process. The documentation describes the performance of this system.
While a human clinician interprets the final numerical result, the device itself provides the measurement without human-in-the-loop performance during the assay execution. Therefore, the performance described is inherently "standalone" for the assay's function.
7. The Type of Ground Truth Used
The "ground truth" for this study is essentially the results obtained from the predicate device (VITROS Immunodiagnostic Products Free T3 assay, original formulation).
The document states: "Equivalence was demonstrated using manufactured reagents along with patient samples with measured Free T3 values spanning the assay range." This implies that the new formulation's readings on these patient samples were compared against the established readings of the predicate device on the same samples.
8. The Sample Size for the Training Set
The document does not specify a training set size or mention a distinct "training set" in the context of device development or validation. For chemical assays like this, performance is validated through analytical studies (precision, accuracy, linearity, interference, etc.) rather than "training" an AI model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of machine learning or AI, this information is not applicable and not provided. The "ground truth" for the predicate device's original establishment would have been through its own rigorous validation studies against reference methods, but this is not detailed for the new formulation's submission which focuses on substantial equivalence.
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DEC 22 1999
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: K994145
-
Ortho-Clinical Diagnostics, Inc. 1. Submitter name, 100 Indigo Creek Drive address, Rochester. New York 14626-5101 contact (716) 453-4041
Marlene A. Shulman Contact Person: -
Date Special 510(k) prepared: December 7, 1999 2. Preparation date
-
Trade or Proprietary Name: 3. Device name VITROS Immunodiagnostic Products Free T3 Reagent Pack VITROS Immunodiagnostic Products Free T3 Calibrators
: Free T3 assay Common Name Classification Name: Total triiodothyronine test system ( 21 CFR 862.1710).
- The VITROS Immunodiagnostic Products Free T3 Reagent Pack (new 4. Predicate device formulation) and VITROS Immunodiagnostic Products Free T3 Calibrators (new formulation) are substantially equivalent to the VITROS Immunodiagnostic Products Free T3 Reagent Pack (original formulation) and VITROS Immunodiagnostic Products Free T3 Calibrators (original formulation).
Continued on next page
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510(k) Summary, Continued
-
The VITROS Immunodiagnostic System uses luminescence as the signal in 5. Device the quantitative and semi-quantitative determination of selected analytes in description human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements: -
- The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Free T3 Reagent Pack, VITROS Immunodiagnostic Products Free T3 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Free T3 assay.
-
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
| 6. Deviceintendeduse | VITROS Free T3 Reagent PackFor in vitro diagnostic use only.The VITROS Free T3 Reagent Pack quantitatively measures FreeTriiodothyronine ( Free T3) concentration in serum and plasma (EDTA orheparin).VITROS Free T3 Calibrators - For in vitro use in the calibration of the |
|---|---|
| ------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
VITROS Immunodiagnostic System for the quantitative measurement of Free T3 in serum and plasma ( EDTA or heparin).
Continued on next page
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510(k) Summary, Continued
- The VITROS Immunodiagnostic Products Free T3 Reagent Pack (new 7. Comparison formulation) and VITROS Immunodiagnostic Products Free T3 Calibrators to predicate device (new formulation) are substantially equivalent to VITROS Immunodiagnostic Products Free T3 Reagent Pack for use with human serum which was cleared by the FDA (K970016) for in vitro diagnostic use.
Table 1 lists the characteristics of the assays performed using the VITROS Free T3 assay (new formulation) and the VITROS Free T3 assay (original formulation).
| DeviceCharacteristic | New DeviceVITROS Free T3 assay(New formulation) | Predicate DeviceVITROS Free T3 assay(Original formulation) |
|---|---|---|
| Sample type | Serum and plasma (EDTA orheparin). | Serum. |
| Antibody | One sheep polyclonal anti-T3antibody in conjugate reagent.Immunogen: T3-edestin (aplant seed globulin.Source: Purchased from asupplier. | One sheep polyclonal anti-T3antibody in conjugate reagent.Immunogen: T3-bovine serumalbumin.Source: In-house. |
| Calibration range | 0-35 pmol/L | 0-35 pmol/L |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | VITROS ImmunodiagnosticSystem | VITROS ImmunodiagnosticSystem |
| Sample volume | 25µL | 25µL |
| Incubation time andtemperature | 16 minutes at 37°C withshaking | 16 minutes at 37°C withshaking |
Table 1 List of Assay Characteristics: Comparison to Predicate Device
Continued on next page
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510(k) Summary, Continued
- Conclusions The information presented in the pre-market notification demonstrate that the performance of the VITROS Free T3 assay (new formulation) for use with human serum and plasma (EDTA or heparin) is substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using manufactured reagents along with patient samples with measured Free T3 values spanning the assay range.
The information presented in the premarket notification provide a reasonable assurance that the VITROS Free T3 assay (new formulation) for use with human serum and plasma (EDTA or heparin) is safe and effective for the stated intended use.
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract emblem that resembles an eagle or other bird-like figure. The emblem is composed of three curved lines that suggest the wings and body of the bird.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 22 1999
Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, New York 14626
K994145 Re:
: ・
Trade Name: VITROS Immunodiagnostic Products Free T3 Reagent Pack VITROS Immunodiagnostic Products Free T3 Calibrators Regulatory Class: II Product Code: JIS, CPD Dated: December 7, 1999 Received: December 8, 1999
Dear Ms. Shulman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 regulations.
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Page 2
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 regulation (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 infornation 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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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Statement of Intended Use
S10(k) Number (if known):
Device Nume:
Indications for Use:
VITROS Immunodiagnostic Products Free T3 Reagent Pack VITROS Immunodiagnostic Products Free T3 Calibrators
VITROS Free T3 Reagent Pack For in vitro diagnostic use only. The VITROS Free T3 Reagent Pack quantitatively measures free triodothyronine (FT3) concentration in serum and plasma (EDTA or heparin) to aid in the differential diagnosis of thyroid disease.
VITROS Free T3 Calibrators - For in virro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Free T3 in serum and plasma (EDTA or heparin)
Scan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K974145
Di Div 510
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Free T3 Reagent Pack
VITROS Immunodiagnostic Products Free T3 Calibrators
Page 1 of 1
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.