(260 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the performance studies section does not mention any AI/ML specific validation methods.
No
The provided text does not contain any information indicating that the device is used for therapy or treatment. It mentions "safe and effective," "nonclinical investigations," and "in vitro studies," which typically relate to diagnostics or assessment rather than therapeutic intervention.
No
The provided text mentions "Reasonable assurance that this device is safe and effective was determined through the use of valid scientific nonclinical investigations including in vitro studies." This statement, along with the mention of "relative sensitivity and specificity data," suggests performance evaluation indicative of a medical device, but it does not specify diagnosis as its intended use. Without an "Intended Use" or "Indications for Use" section that clearly states the device is used for diagnosing conditions, it cannot be confirmed as a diagnostic device based on the provided information.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to definitively say whether the device includes hardware components or is purely software.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use/Indications for Use: While the specific intended use is not provided, the fact that it has this section is a strong indicator of a medical device.
- Summary of Performance Studies: The statement "Reasonable assurance that this device is safe and effective was determined through the use of valid scientific nonclinical investigations including in vitro studies" is the most compelling evidence. "In vitro" specifically refers to studies conducted outside of a living organism, typically in a lab setting using biological samples. This is the hallmark of IVD testing.
- Key Metrics: The mention of "Relative sensitivity and specificity data" are common performance metrics used to evaluate the accuracy of diagnostic tests, including IVDs.
Why it's not definitively confirmed (but still very likely):
- Missing Information: The lack of information in many sections (Device Description, Mentions image processing/AI/DNN/ML, Input Imaging Modality, Anatomical Site, Indicated Patient Age Range, Intended User/Care Setting, Training/Test Set descriptions, Predicate/Reference Devices) prevents a complete picture. However, the presence of "in vitro studies" is a very strong indicator.
In summary, the explicit mention of "in vitro studies" in the performance summary makes it highly probable that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Reasonable assurance that this device is safe and effective was determined through the use of valid scientific nonclinical investigations including in vitro studies. The results of these studies are summarized in the attached Technical Insert. This device is effective when tested under the conditions for its Each test kit contains a technical insert which intended use.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
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)
Raw performance data Intended use of the product Limitations of the product Relative sensitivity and specificity data Directions for procedure
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative sensitivity and specificity data
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.
Not Found
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
§ 866.3820
Treponema pallidum nontreponemal test reagents.(a)
Identification. Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
JUL 30 1996
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850
RE: 510(k) Submission for RPR Liquid Controls Summary of of a a n d Safety -Effectiveness
November 8, 1995
Dear Sir:
In accordance with 21 CFR Chapter 1, Subpart E, Sec. 807.93, and as part of the 510(k) submission for the RPR Liquid Controls, the following information is provided.
Reasonable assurance that this device is safe and effective was determined through the use of valid scientific nonclinical investigations including in vitro studies. The results of these studies are summarized in the attached Technical Insert.
This device is effective when tested under the conditions for its Each test kit contains a technical insert which intended use. provides adequate directions and precautions for use. Lastly, each insert contains information on the limitations and the performance characteristics of the test (including relative sensitivity and specificity data) when used according to the directions.
SUMMARY OF SAFETY AND EFFECTIVENESS DATA:
Raw performance data Intended use of the product Limitations of the product Relative sensitivity and specificity data Directions for procedure 510(k) Submission
Should there be any questions concerning this matter, please contact me at (706)736-6011.
Sincerely,
Hand D. Mall
David A. Wall Manager, Immunodiagnostics
1
| Site: Mich. Dept.PH | |||||||
|---|---|---|---|---|---|---|---|
| PI: H. Stiefel | |||||||
| Date | 1897-15 | ||||||
| R | REMEL Pos Crtl | Bom-5 | |||||
| Batom MOFH 6346 RW | Reference Pos Crtl | REMEL RPR CARD TEST CONTROLS Comparative Date | |||||
| bom-5 | |||||||
| SR | |||||||
| MOPH 6346 RW | REMEL Neg Crtl | Reference Neg Crtl | |||||
| 10-95 | R | Rmod | R W | R W | N | ||
| 11-95 | R | Rmod | R W | R W | N | ||
| 14-95 | R | Rmod | R W | R W | N | ||
| -21-95 | R | Rmod | R W | R W | N | ||
| -24-95 | R | Rmod | R W | R W | N | ||
| -27-95 | R | Rmod | R W | R W | N | ||
| -31-95 | R | Rmod | R W | R W | N | ||
| 8-3-95 | R | Rmod | R W | R W | N | ||
| 8-8-95 | R | Rmod | R W | R W | N | ||
| 8-12-95 | R | Rmod | R W | R W | N | ||
| 8-17-95 | R | Rmod | R W | R W | N | ||
| 8-18-95 | R | Rmod | R W | R W | N | ||
| 8-21-95 | R | Rmod | R W | R W | N | ||
| 8-22-95 | R | Rmod | R W | R W | N | ||
| 8-23-95 | R | Rmod | R W | R W | N | ||
| 8-25-95 | R | Rmod | R W | R W | N | ||
| 8-28-95 | R | Rmod | R W | R W | N | ||
| 8-30-95 | R | Rmod | R W | R W | N | ||
| 9-1-95 | R | Rmod | R W | R W | N | ||
| 9-5-95 | R | Rmod | R W | R W | N | ||
| 9-6-95 | R | Rmod | R W | R W | N | ||
| 9-7-95 | R | Rmod | R W | R W | N | ||
| 10-27-95 | R | Rmod | R W | R W | N | ||
| 10-3-95 | R | Rmod | R W | R W | N |
e גרייטער יידישער פ
ರ್ಥ
2
site - UTex .
PIC : Hartwell
| REMEL RPR CARD TEST CONTROLS Comparative Data | |||||
|---|---|---|---|---|---|
| Date | REMEL Pos Ctrl | Reference Pos Ctrl | REMEL Neg Ctrl | Reference Neg Ctrl | |
| 7/3/95 | R / | ||||
| mR | R / mR | NR | NR | ||
| 7/5/95 | R / mR | R / mR | NR | NR | |
| 7/6/95 | R / me | R / me | NR | NR | |
| 7/12/95 | R / mR | R / mR | NR | NR | |
| 7/21/95 | R / mR | R / mR | NR | NR | |
| 7/24/95 | R / me | R / me | NR | NR | |
| 7/25/95 | R / me | R / me | NR | NR | |
| 7/29/95 | R / me | R / me | NR | NR | |
| 7/31/95 | R / me | R / me | NR | NR | |
| 8/1/95 | R / me | R / me | NR | NR | |
| 8/3/95 | R / me | R / me | NR | NR | |
| 8/4/95 | R / mR | R / mR | NR | NR | |
| REMEL RPR CARD TEST CONTROLS Comparative Data | Site: | ||||
| Date | REMEL Pos Ctrl | Reference Pos Ctrl | REMEL Neg Ctrl | Reference Neg Ctrl | |
| 8/10/95 | R4+ / mR | R4+ / me1+ | NR | NR | |
| 8/16/95 | R / me | R / me | NR | NR | |
| 9/2/95 | R / me | R / me | NR | NR | |
| 9/22/95 | R / mR | R / mR | NR | NR |
l ﺎﺭ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
ii
3
Site: VTex.
PI: Hartwell
الادا
11