(55 days)
Not Found
No
The description details a standard immunoassay reagent and its mechanism of action, which relies on chemical reactions and enzymatic activity, not AI/ML algorithms. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is a reagent used for diagnostic testing to measure thyroxine levels, which aids in the diagnosis and treatment of thyroid disorders, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" states that the ACE® T4 Reagent is "used in the diagnosis and treatment of thyroid disorders." Additionally, it performs "quantitative determination of thyroxine in human serum," which is a diagnostic measurement.
No
The device description clearly outlines a chemical reagent kit used for laboratory testing, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "quantitative determination of thyroxine in human serum." This is a test performed on a biological sample (serum) outside of the body to provide information about a person's health status.
- Diagnosis and Treatment: The intended use also states it is "used in the diagnosis and treatment of thyroid disorders." This directly links the test results to clinical decision-making.
- Device Description: The description details a chemical assay that measures a substance (thyroxine) in a sample (serum) using reagents and an analyzer. This is characteristic of an in vitro diagnostic test.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K944703) indicates that this device is being compared to a previously cleared device, which is a common process for IVDs seeking regulatory approval.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ACE® T4 Reagent is intended for use in the quantitative determination of thyroxine in human serum.
ACE" T4 Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of thyroxine in serum using the ACE clinical chemistry analyzer.
Product codes (comma separated list FDA assigned to the subject device)
KLI, JIS
Device Description
The ACE® T4 Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate Coniugate reagent. thyroxine from the plasma-binding proteins. The dissociated thyroxine in the sample competes with an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled thyroxine for a fixed amount of anti-thyroxine specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between thyroxine concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test results submitted in the premarket notification include within-run and between-run precision and method correlation.
Performance Summary
Assay Range: 0.47 µg/dL to 20 µg/dL
Precision: Within Run 3.7 %CV, Between Run 4.6 %CV
Correlation vs Hitachi 717: Slope 1.070, Intercept -0.405, r 0.9824, N 50.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: Within Run 3.7 %CV, Between Run 4.6 %CV
Correlation r: 0.9824
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.
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.
Not Found
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).
Not Found
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(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.
0
510(k) PREMARKET NOTIFICATION ACE® T4 Reagent
K 981377
SUMMARY OF SAFETY AND EFFECTIVENESS
In lieu of a 510(k) statement under 513(i) of the Act, this Summary of Safety and Effectiveness is provided as a 510(k) summary for disclosure to any other persons/companies without specific written authorization from Schiapparelli Biosystems, Inc.
Submitter
Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield, NJ 07004 Phone: (973) 882-8630
Contact Person
Steven Dalessio Manager, Quality Assurance/Regulatory Affairs Phone: (973) 882-8630
Device Names
| Proprietary Name: | ACE® T4 Reagent |
|---|---|
| Common Name: | Enzyme immunoassay for thyroxine |
| Classification Name: | Thyroxine test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Thyroxine (T4) Reagent |
| [510(k) Number K944703] |
Device Description
The ACE® T4 Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate Coniugate reagent. thyroxine from the plasma-binding proteins. The dissociated thyroxine in the sample competes with an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled thyroxine for a fixed amount of anti-thyroxine specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between thyroxine concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
Intended Use of the Device
ACE® T4 Reagent is intended for use in the quantitative determination of thyroxine in human serum.
1
510(k) PREMARKET NOTIFICATION ACE® T4 Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Trade Name | DRI Thyroxine (T4) Enzyme | |
| Immunoassay | ACE® T4 Reagent | |
| Reference No. | K944703 | TBD |
| Analyte | Thyroxine | Thyroxine |
| Intended Use | Quantitative determination of | |
| thyroxine | Quantitative determination of | |
| thyroxine | ||
| Methodology | Enzyme immunoassay | Enzyme immunoassay |
| Reagents | ||
| Reagent 1 | ||
| Volume | Liquid; Antibody/Substrate | |
| 210 µL | Liquid; Antibody/Substrate | |
| 210 µL | ||
| Reagent 2 | ||
| Volume | Liquid; Enzyme conjugate | |
| 70 µL | Liquid; Enzyme conjugate | |
| 70 µL | ||
| Specimen | ||
| Type | ||
| Volume | Serum and plasma | |
| 5 µL | Serum | |
| 5 µL | ||
| Assay System | ||
| Reagent 1 + Sample | ||
| Reagent 2 | ||
| Temperature | Incubate 288 sec | |
| Read 72 to 132 sec (12 sec intervals) | ||
| 37 °C | Incubate 240 sec | |
| Read 63 and 203 sec | ||
| 37 °C | ||
| Detection Method | ||
| Type | ||
| Wavelength, nm | Spectrophotometric | |
| Bichromatic: 340/415 | Spectrophotometric | |
| Bichromatic: 340/505 |
2
510(k) PREMARKET NOTIFICATION ACE® T4 Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
PERFORMANCE ASSESSMENT
Non-clinical test results submitted in the premarket notification include within-run and between-run precision and method correlation. Following is a data summary.
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Performance Summary | ||
| Assay Range | ||
| Precision | ||
| Within Run | ||
| Between Run | 0.7 µg/dL to 20 µg/dL | |
| 5.4 %CV | ||
| 4.3 %CV | 0.47 µg/dL to 20 µg/dL | |
| 3.7 %CV | ||
| 4.6 %CV | ||
| Correlation vs | ||
| Slope | ||
| Intercept | ||
| r | ||
| N | Commercial thyroxine assay | |
| 1.02 | ||
| -0.63 | ||
| 0.993 | ||
| 108 | Hitachi 717 | |
| 1.070 | ||
| -0.405 | ||
| 0.9824 | ||
| 50 |
Based on these data, the Schiapparelli Biosystems ACE® T4 Reagent is substantially equivalent to the predicate device (Diagnostic Reagents, Inc. Thyroxine (T4) Enzyme Immunoassay). On this basis, the reagent is determined to be safe and effective for its intended use. Performance details are included in the reagent product labeling.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circle around the eagle. The eagle is black and white, and the text is in a simple, sans-serif font. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
JUN 1 0 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Steven Dalessio . Manager, Quality Assurance/Regulatory Affairs Schiapparelli Biosystems, Inc. 368 Passaic Avenue 07004 Fairfield, New Jersey
Re: K981377 ACE® T4 Reagent II Requlatory Class: Product Code: KLI, JIS April 15, 1998 Dated: Received: April 16, 1998
Dear Mr. Dalessio:
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 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 The general controls provisions of the Act 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. ਕੇ 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 In addition, FDA may publish further announcements action. 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 leqally 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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
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
5
98
l of Page 1
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K981377 |
| Device Name: | ACE" T4 Reagent |
Indications For Use:
..
ACE" T4 Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of thyroxine in serum using the ACE clinical chemistry analyzer.
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Clinical Laboratory Devices
| 510(k) Number | K981377 |
|---|---|
| --------------- | --------- |
(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_
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
(Optional Format 1-2-96)