(119 days)
934830
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No
The description details a traditional immunoassay based on antibody binding and colorimetric detection, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is a diagnostic test for pregnancy, not a therapeutic device. It determines the presence of hCG but does not treat or cure any condition.
Yes
The device determines the presence of Human Chorionic Gonadotropin (hCG) in urine or serum, which is used to diagnose pregnancy.
No
The device description clearly outlines a physical strip assay that uses antibodies and membrane technology to detect hCG, indicating it is a hardware-based diagnostic test, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of Human Chorionic Gonadotropin in urine or serum." This is a diagnostic test performed on biological samples taken from the body.
- Device Description: The description details a method for analyzing a biological sample (urine or serum) to detect a specific substance (hCG) for diagnostic purposes (determining pregnancy).
- Performance Studies: The document describes clinical trials and performance metrics (accuracy, sensitivity, specificity) based on testing patient samples. This is characteristic of IVD devices which require validation for their intended diagnostic use.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The Technical Chemicals and Products Inc. ("TCPI") One Step™ Pregnancy hCG strip assay is a qualitative, sandwich dye conjugate immunoassay for the determination of Human Chorionic Gonadotropin in urine or serum.
Product codes
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Device Description
The method employs a unique combination of monoclonal and polyclonal antibodies to selectively identify hCG in test samples with a high degree of sensitivity using a unique patented membrane technology. In less than 5 minutes, elevated levels of hCG as low as 25 mIU/ml can be detected. If the test is to be used on serum the sample must be diluted according to the directions for the One Step™ Pregnancy hCG serum diluent (cat XXXX). As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose color band when hCG concentration is greater than 25 mIU/ml. In the absence of hCG, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative zone. Unbound conjugate binds to the reagents in the negative control zone, producing a pink-rose (magenta) color band, demonstrating that the reagents and device are functioning correctly.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
When tested blind in 150 documented (Pregnant/not pregnant) patient samples the test correctly identified all 150 samples (90 pregnant and 60 not pregnant). There were no false negatives or positives.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The TCPI One Step™ Pregnancy hCG strip hCG test has been extensively tested against substances known to interfere with pregnancy testing with no apparent interferences. The specificity of the reaction has been tested against other hormones with no cross reactivity noted. The sensitivity of the product is routinely tested and found to be 25 mIUml [See Stability testing]. When tested blind in 150 documented (Pregnant/not pregnant) patient samples the test correctly identified all 150 samples (90 pregnant and 60 not pregnant). There were no false negatives or positives. TCPI has produced and distributed in excess of 19,604,093 strips World wide for the past four (4) years with very few complaints. All of the complaints have been related to shipping problems between the foreign distributor and the retail outlets or not following the directions for use. In a series of clinical trials the combination of the diluent reagent and One Step™ Pregnancy hCG Strip were compared to reference methods and samples (urine and serum/plasma) In all 385 patient comparisons the results of the diluent reagent plus the One Step™ Pregnancy hCG strip agreed with the reference methods employed in the studies. Based upon the results of the clinical testing the accuracy, sensitivity, and specificity all equal 100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The sensitivity of the product is routinely tested and found to be 25 mIUml. Based upon the results of the clinical testing the accuracy, sensitivity, and specificity all equal 100%.
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.
934830
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
MAR 1 9 1996
Summary of Safety and Effectiveness
This summary of safety and effectiveness was originally prepared by Technical Chemicals and Products Inc. for inclusion in its One Step™ Pregnancy hCG strip. This represents an expansion of the intended use to include both serum and plasma as well as urine. For any questions contact Dr. Cleve W. Laird, Exec. V.P., Technical Chemicals and Products Inc. at 954-971-7595. The Predicate device is One Step™ Pregnancy hCG strip a class II device cleared under 510K # 934830.
The Technical Chemicals and Products Inc. ("TCPI") One Step™ Pregnancy hCG strip assay is a qualitative, sandwich dye conjugate immunoassay for the determination of Human Chorionic Gonadotropin in urine or serum. The method employs a unique combination of monoclonal and polyclonal antibodies to selectively identify hCG in test samples with a high degree of sensitivity using a unique patented membrane technology. In less than 5 minutes, elevated levels of hCG as low as 25 mIU/ml can be detected. If the test is to be used on serum the sample must be diluted according to the directions for the One Step™ Pregnancy hCG serum diluent (cat XXXX).
As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose color band when hCG concentration is greater than 25 mIU/ml. In the absence of hCG, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative zone. Unbound conjugate binds to the reagents in the negative control zone, producing a pink-rose (magenta) color band, demonstrating that the reagents and device are functioning correctly.
The TCPI One Step™ Pregnancy hCG strip hCG test has been extensively tested against substances known to interfere with pregnancy testing with no apparent interferences. The specificity of the reaction has been tested against other hormones with no cross reactivity noted. The sensitivity of the product is routinely tested and found to be 25 mIUml [See Stability testing]. When tested blind in 150 documented (Pregnant/not pregnant) patient samples the test correctly identified all 150 samples (90 pregnant and 60 not pregnant). There were no false negatives or positives. TCPI has produced and distributed in excess of 19,604,093 strips World wide for the past four (4) years with very few complaints. All of the complaints have been related to shipping problems between the foreign distributor and the retail outlets or not following the directions for use.
1
In a series of clinical trials the combination of the diluent reagent and One Step™ Pregnancy hCG Strip were compared to reference methods and samples (urine and serum/plasma) In all 385 patient comparisons the results of the diluent reagent plus the One Step™ Pregnancy hCG strip agreed with the reference methods employed in the studies. Based upon the results of the clinical testing the accuracy, sensitivity, and specificity all equal 100%.