(135 days)
No
The device description details a manual, immunological agglutination test kit with visual interpretation, and there is no mention of AI/ML in the text.
No.
This device is an in-vitro diagnostic test kit used to determine fetal lung maturity. It does not provide any therapy or treatment.
Yes
The device is described as an "immunological semi-quantitative agglutination test for determining the presence of phosphatidylglycerol in human amniotic fluid at concentrations indicative of fetal lung maturity," which is a diagnostic purpose. The "Intended Use / Indications for Use" section explicitly states its use for "immunological detection...to determine fetal lung maturity."
No
The device description clearly outlines a physical kit containing multiple components, including reagents, controls, and agglutination cards, which are hardware components. It is an in-vitro diagnostic test kit, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "immunological detection of phosphatidylglycerol (PG) in amniotic fluid to determine fetal lung maturity." This involves testing a biological sample (amniotic fluid) in vitro (outside the body) to gain diagnostic information about a physiological state (fetal lung maturity).
- Device Description: The description details a "semi-quantitative agglutination test" using reagents and controls to analyze the amniotic fluid sample. This is a typical format for an in vitro diagnostic test kit.
- Anatomical Site: The test is performed on "amniotic fluid," which is a biological sample collected from the body.
- Intended User / Care Setting: The intended users are "laboratory personnel in a hospital and/or clinical laboratory," which is where IVD tests are typically performed.
The device fits the definition of an IVD as it is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state or concerning a congenital abnormality.
N/A
Intended Use / Indications for Use
for use as an immunologic intended AmnioStat-FLM-PG is semiguantitative agglutination test for determining the presence of phosphatidylglycerol in human amniotic fluid at concentrations indicative of fetal lung maturity.
The AmnioStat-FLM-PG Kit is intended to be used for the immunological detection of phosphatidylglycerol (PG) in amniotic fluid to determine fetal lung maturity of the fetus collected from transabdominal or vaginal pool samples.
Product codes (comma separated list FDA assigned to the subject device)
JHG
Device Description
The AmnioStat-FLM-PG Kit is an immunological semi-quantitative agglutination test for determining the presence of phosphatidylglycerol in human amniotic fluid at concentrations indicative of fetal lung maturity. The AmnioStat-FLM-PG Kit is comprised of five (5) components and a disposable agglutination cards (cardboard with laminate). The five (5) components that comprise the kit include three (3) kit controls, Negative Control, Catalog #91013, Low Positive Control, Catalog #91027, High Positive Control, Catalog #91028, two (2) reagents, Reagent A, Catalog #91012 and Reagent B, Catalog #91029, and one (1) Buffer, Catalog #91011.
The three (2) controls (negative, low positive, and high positive) in the AmnioStat-FLM-PG Kit are run with each test. The AmnioStat-FLM-PG Kit can be used to run six (6) patient test samples. Each patient sample is run on an individual agglutination card with a set of controls. Please refer to the photographs of the AmnioStat-LM-PG Kit presented in Appendix D of the submission.
The AmnioStat-FLM-PG Kit is a next generation kit based upon the same immunological agglutination test as AmnioStat-FLM (K822150) previously cleared for marketing. The immunological agglutination reaction is the same between the AmnioStat-FLM (K822150) and the AmnioStat-FLM-PG kit. The AmnioStat-FLM-PG Kit incorporates the use of Sudan Black B into one of the kit reagents which makes the differentiation of the three (3) kit controls more distinguishable. The AmnioStat-FLM (K822150) is performed on a glass slide that requires the use of a mirror to distinguish and differentiate the kit controls based upon clarity of the background and the size of the agglutinated particles. The AmnioStat-FLM-PG is performed on a disposable agglutination card that is white and does not require the use of a mirror to distinguish and differentiate the kit controls.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
amniotic fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The AmnioStat-FLM-PG test kit is to be used by laboratory personnel in a hospital and/or clinical laboratory.
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)
The AmnioStat-FLM-PG Kit has been evaluated by five (5) independent field laboratories that currently use the AmnioStat-FLM test kit. The response and feedback from the laboratories that evaluated the kit indicates it was well received in terms of its application, ease of use, and effectiveness in the determining fetal lung maturity in human amniotic fluid.
In addition, clinical comparison data was also generated for seventy-three (73) patient samples that were tested between the two (2) clinical laboratories. The results of the comparison study yielded no false positive test results and demonstrated that the AmnioStat-FLM-PG kit performs in accordance with the intended use of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
no false positive test results
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
§ 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.
(a)
Identification. A lecithin/sphingomyelin ratio in amniotic fluid test system is a device intended to measure the lecithin/sphingomyelin ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats or fat-like substances containing phosphorus). Measurements of the lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating fetal maturity.(b)
Classification. Class II.
0
OC1 1 8 2006
Kcx61549
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
| Submitted by: | Irvine Scientific Sales Co., Inc.
2511 Daimler Street
Santa Ana, CA 92705-5588 |
|---------------|--------------------------------------------------------------------------------------|
| | Telephone: (800) 437-5706
Facsimile: (949) 261-6522 |
| | Contact: Wendell Lee, Pharm. D. |
| | Date Submitted: June 2, 2006 |
Device Identification:
Trade Name: | AmnioStat-FLM-PG |
---|---|
Common Name: | AmnioStat |
Classification Name: | Lecithin/Sphingomyelin Ratio in Amniotic Fluid |
(21 CFR, 862.1455) |
Predicate Device:
AmnioStat-FLM (K822150), Lecithin/Sphingomyelin ratio in amniotic fluid test system (21 CFR 862.1455)
Description:
The AmnioStat-FLM-PG Kit is an immunological semi-quantitative agglutination test for determining the presence of phosphatidylglycerol in human amniotic fluid at concentrations indicative of fetal lung maturity. The AmnioStat-FLM-PG Kit is comprised of five (5) components and a disposable agglutination cards (cardboard with laminate). The five (5) components that comprise the kit include three (3) kit controls, Negative Control, Catalog #91013, Low Positive Control, Catalog #91027, High Positive Control, Catalog #91028, two (2) reagents, Reagent A, Catalog #91012 and Reagent B, Catalog #91029, and one (1) Buffer, Catalog #91011.
1
The three (2) controls (negative, low positive, and high positive) in the AmnioStat-FLM-PG Kit are run with each test. The AmnioStat-FLM-PG Kit can be used to run six (6) patient test samples. Each patient sample is run on an individual agglutination card with a set of controls. Please refer to the photographs of the AmnioStat-LM-PG Kit presented in Appendix D of the submission.
The AmnioStat-FLM-PG Kit is a next generation kit based upon the same immunological agglutination test as AmnioStat-FLM (K822150) previously cleared for marketing. The immunological agglutination reaction is the same between the AmnioStat-FLM (K822150) and the AmnioStat-FLM-PG kit. The AmnioStat-FLM-PG Kit incorporates the use of Sudan Black B into one of the kit reagents which makes the differentiation of the three (3) kit controls more distinguishable. The AmnioStat-FLM (K822150) is performed on a glass slide that requires the use of a mirror to distinguish and differentiate the kit controls based upon clarity of the background and the size of the agglutinated particles. The AmnioStat-FLM-PG is performed on a disposable agglutination card that is white and does not require the use of a mirror to distinguish and differentiate the kit controls.
Intended Use:
for use as an immunologic intended AmnioStat-FLM-PG is semiguantitative agglutination test for determining the presence of phosphatidylglycerol in human amniotic fluid at concentrations indicative of fetal lung maturity.
The AmnioStat-FLM-PG test kit is to be used by laboratory personnel in a hospital and/or clinical laboratory.
Performance Data:
The AmnioStat-FLM-PG Kit has been evaluated by five (5) independent field laboratories that currently use the AmnioStat-FLM test kit. The response
2
and feedback from the laboratories that evaluated the kit indicates it was well received in terms of its application, ease of use, and effectiveness in the determining fetal lung maturity in human amniotic fluid.
In addition, clinical comparison data was also generated for seventy-three (73) patient samples that were tested between the two (2) clinical laboratories. The results of the comparison study yielded no false positive test results and demonstrated that the AmnioStat-FLM-PG kit performs in accordance with the intended use of the product.
Additional Information:
Functionality of the three (3) kit controls (negative, low positive, and high positive) in the AmnioStat-FLM-PG Kit with regards to differentiation in appearance is performed as a condition of release. Please refer to the proposed labeling presented in Section 14 of this submission.
Conclusion:
The results from the field testing of this product demonstrates that the AmnioStat-FLM-PG Kit is suitable for its intended use, meets the criteria as outlined in 21 CFR Section 862.1455, Lecithin/Sphingomyelin ratio in amniotic fluid test system.
3
Image /page/3/Picture/1 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 circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Wendell Lee, Pharm.D. Vice President Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588
OCT 1 8 2006
Re: K061549
Trade/Device Name: AminoStat-FLM-PG Regulation Number: 21 CFR 862.1455 Regulation Name: Lecithin/sphingomyelin ratio in amniotic fluid test system Regulatory Class: Class II Product Code: JHG Dated: September 25, 2006 Received: September 26, 2006
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbaanding 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins lotter will anow you w organ marketing of substantial equivalence of your device to a legally promation notineditor. "The PD's in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, rr you dost o specific instition and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may overn 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/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutz
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K061549
Device Name:
AmnioStat-FLM-PG
Indications For Use:
The AmnioStat-FLM-PG Kit is intended to be used for the immunological detection of phosphatidylglycerol (PG) in amniotic fluid to determine fetal lung maturity of the fetus collected from transabdominal or vaginal pool samples.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C.A.C.
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K061549