(283 days)
StatusFirst™ hCG Serum/Urine test is in vitro diagnostic use for a qualitative detection of Human Chorionic Gonadotropin(hCG) in serum or urine for the detection of pregnancy.
Reflectance photometer for the measurement of concentration of analyte in various assays manufactured by PBM. The concentration is measured by density of light reflectance.
Reflectance photometer for a reading of test signal instead of visual reading in various qualitative assays manufactured by PBM.
StatusFirst™ hCG Serum/Urine is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in serum or urine. The device is used with DXpress™ Reader.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence rather than explicit quantitative acceptance criteria. Therefore, the "acceptance criteria" here refer to the performance of the predicate device, which the new device aims to match or exceed.
| Feature/Metric | Acceptance Criteria (Predicate Device K993065: Icon 25 hCG) | Reported Device Performance (StatusFirst™ hCG Serum/Urine) |
|---|---|---|
| Detection Method | Immunochromatographic assay | Immunochromatographic assay |
| Qualitative Test | Yes | Yes |
| Detection Limit | 25 mIU/mL hCG in serum or urine | 25 mIU/mL hCG in serum or urine |
| Agreement with Predicate | N/A (Predicate performance itself) | 93% agreement (when 116 specimens compared for urine or serum) |
| Result Reading Method | Visual | DXpress Reader |
| Result Read Time (Urine) | 3 min | 5 min |
| Result Read Time (Serum) | 5 min | 5 min |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 116 specimens (for both urine and serum combined, or 116 for urine and 116 for serum separately - the wording "when 116 specimens were compared for urine test or for serum test" is slightly ambiguous but implies a significant sample size for comparison).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the context of an FDA submission for a "StatusFirst™ hCG Serum/Urine" device suggests human clinical samples were used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The comparison is made against a legally marketed predicate device (Icon 25 hCG), implying the predicate's results served as a comparative "ground truth" or reference, rather than independent expert adjudication.
4. Adjudication Method for the Test Set
This information is not provided. The study compares the results of the StatusFirst™ hCG Serum/Urine device with the Icon 25 hCG test. The predicate device's readings served as the reference point. The document notes that "disagreements were shown in the borderline samples," where "StatusFirst™ hCG Serum/Urine read the borderline samples as borderline level, whereas predicate device read most of borderline samples as positive," indicating a direct comparison rather than an adjudication process involving multiple third-party experts.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or described. The device, DXpress™ Reader, is a reader for the hCG test strips, providing an objective reading instead of a visual reading by a human. The comparison is between an automated reading (DXpress Reader) and a visual reading (Icon 25 hCG), not an AI assisting human readers.
6. Standalone Performance
Yes, a standalone performance study was done. The 93% agreement reported is the direct performance of the StatusFirst™ hCG Serum/Urine device (read by the DXpress Reader) when compared against the predicate device. This is the device's performance without human-in-the-loop decision making, as the DXpress Reader automates the result interpretation.
7. Type of Ground Truth Used
The "ground truth" used for comparison was the results obtained from a legally marketed predicate device, the Icon 25 hCG test. This is an existing device comparison rather than an independent gold standard like pathology or clinical outcomes.
8. Sample Size for the Training Set
This information is not provided in the document. The document describes a performance evaluation of the final product, not the development or training of the device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. Given that the document describes the performance of a medical device rather than a machine learning algorithm, the concept of a "training set" and "ground truth for the training set" in the context of AI is not explicitly relevant or discussed here. The device is an immunochromatographic assay read by a reflectance photometer, which implies established chemical/biological principles rather than a machine learning model trained on data.
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JAN 2 3 2006
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is: K050955
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- Date of Summary: Dec. 16, 2005
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- Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 Phone 732-274-1000 732-274-1010 Fax
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- Device Name
Trade Names: StatusFirst™ hCG Serum/Urine Name: Immunoassay, human Chorionic Classification FDA Gonadotropin (hCG) (Clinical Chemistry Classification Device List)
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- Identification of legally marketed device to which claims equivalence: K993065: Icon 25 hCG by Beckman Coulter
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- Device Description: StatusFirst™ hCG Serum/Urine is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in serum or urine. The device is used with DXpress™ Reader.
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- Intended Use: StatusFirst™ hCG Serum/Urine test is in vitro diagnostic use for a qualitative detection of Human Chorionic Gonadotropin(hCG) in serum or urine for the detection of pregnancy.
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- Subtantial Equivalance: StatusFirst™ hCG Serum/Urine is substantially equivalent to premarketed device Icon 25 hCG test. Both products use the same immunochromatographic assay to detect hCG in serum or urine qualitatively. The tests demonstrated 93% agreement when 116 specimens were compared for urine test or for serum test. The disagreements were shown in the borderline samples. StatusFirst™ hCG Serum/Urine read the borderline samples as borderline level, whereas predicate device read most of borderline samples as positive.
We may conclude StatusFirst™ hCG Serum/Urine is substantially equivalent to a legally marketed device, K993065, Icon 25 hCG test.
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Name of Manufacturer:
Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, New Jersey 08852
Establishment Registration Number:
2246703
Product Name:
Reader
- A. Trade Name: LifeSign DXpress™
- B. Common or Usual Name:
Reflectance Photometer for clinical use
- C. Classification Name:
Colorimeter, photometer, or spectrophotometer for clinical use (Clinical Chemistry and Clinical Toxicology device classification)
hCG test
- A. Trade Name: StatusFirst™ hCG Serum/Urine
- B. Common or Usual Name:
- hCG test system
- C. Classification Name:
Immunoassay, human Chorionic Gonadotropin (hCG) (Clinical Chemistry Classification Device List)
Product Classification:
The tentative classification of the device under Section 513 of the Act is made available by the Food and Drug Administration.
Reader
Class: I (General Control) Panel: Clinical Chemistry and Clinical Toxicology Devices Product Classification Code: JJQ - Clinical Chemistry Regulation Number: CFR 862.2300
hCG Test
Class: II (General Control) Panel: Clinical Chemistry and Clinical Toxicology Product Classification Code: JHI Regulation Number: 21CFR 862.1155
Performance Standards:
Princeton BioMeditech Corporation has reviewed the requirement of Section 514 of the Act and has no reason to believe that any performance standards have been established yet for this device.
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Subtantial Equivalance (807, 87f)
StatusFirst™ hCG Serum/Urine Test is substantially equivalent to Icon 25 hCG test (serum and urine use) which is in commercial distribution by Beckman Coulter, CA.
StatusFirst™ hCG Serum/Urine Test vs. Icon 25 hCG test
Similarities:
- Both assays measure hCG in urine or serum. 1.
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- Both assays are in-vitro immunological assays using immunochromatographic method.
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- Both assays give the result with the colored signal.
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- Both assays are qualitative test.
- Both assays detect hCG at 25 mIU/mL in serum or urine. 6.
Differences:
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- StatusFirst™ hCG Serum/Urine Test read the result by DXpress reader, whereas Icon25 hCG read the result visually.
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- StatusFirst™ hCG Serum/Urine Test reads the result at 5 min for both serum and urine samples, whereas Icon25 hCG read the result at 3 min for urine sample and 5 min for serum sample.
Image /page/2/Picture/13 description: The image contains a single digit, specifically the number 6. The number is written in a simple, slightly rounded font. The digit is black and stands out against a white background.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, positioned to the right of the department's name, which is arranged in a circular fashion around the eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 3 2006
Kyung-ah Kim, Ph.D. Associate Director Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction NJ 08852-1905
Re: K050955
Trade/Device Name: LifeSign DXpress™ reader, StatusFirst™ hCG Serum/Urine Regulation Number: 21 CFR$862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI, JJQ Dated: December 20, 2005 Received: December 21, 2005
Dear: Dr. Kim
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, 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 (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).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion 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 Division 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 Guts
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
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Indications for Use
510(k) Number (if known): - K050955-
LifeSign DXpress™ reader, StatusFirst™ hCG Serum/Urine Device Name:
Indications For Use:
- Reflectance photometer for the measurement of concentration of analyte in various assays 1. manufactured by PBM. The concentration is measured by density of light reflectance.
- Reflectance photometer for a reading of test signal instead of visual reading in various 2. qualitative assays manufactured by PBM.
- StatusFirst™ hCG Serum/Urine test is in vitro diagnostic use for a qualitative detection 3. of Human Chorionic Gonadotropin(hCG) in serum or urine for the detection of pregnancy.
Prescription Use: __ X_ AND/OR (Per 21 CFR 801 Subpart D)
Over-The-Counter Use: (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Device Evaluation (OIVD)
Ains Chappie
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.