(32 days)
The Quantitative Determination of Prolactin Hormone Concentration in Human Serum by a Microplate Immunoenzymometric assay. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or the hypothalamus portion of the brain.
Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (IEMA) kit for the determination of prolactin (PRL) in human serum. The proprietary name is Prolactin (PRL) ELISA and the usual name is PRL IEMA. This device classification name is - prolactin test system - product code CFT (per 21 CRF section 862.1625). The Monobind ELISA method is based on two-site immunoassay (sandwich) technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing monoclonal blotinylated anti-PRL antibody, the enzyme-labeled anti-PRL antibody and a serum containing the native antigen (PRL), reaction results between the native antigen (PRL) and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin and biotinylated antibody. After incubation is complete, decantation or aspiration separates the bound fraction. The enzyme activity on the well is directly proportional to the native antigen (PRL) concentration. By utilizing several different serum references of known antigen values, a dose response curve can be generated from which the antigen concentration of an unknown can be ascertained.
The provided text describes the Monobind Inc. Prolactin (PRL) ELISA device and its substantial equivalence to a predicate device. It does not describe an AI medical device, but rather an immunoassay kit for measuring prolactin levels. Therefore, several of the requested categories for AI device studies are not applicable.
Here's the information extracted and organized as best as possible given the provided text:
Device Name: Prolactin (PRL) ELISA (Monobind Inc.)
Device Type: Enzyme immunoassay (IEMA) kit for the quantitative determination of prolactin (PRL) in human serum.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific threshold values. Instead, it describes performance characteristics and compares them to a predicate device to demonstrate substantial equivalence.
| Performance Metric | Acceptance Criteria (Implicit from Predicate/Study Goal) | Reported Device Performance (Monobind ELISA) |
|---|---|---|
| Substantial Equivalence | Demonstration of similar technological characteristics and comparable clinical performance to the predicate device (Ciba Corning ACS 180). | Demonstrated through linear regression, recovery, and linearity studies. |
| Correlation Coefficient | Implied to be high, indicating good method agreement. | 0.973 (indicating good method agreement) |
| Linear Regression Equation | Implied to be close to y=x (slope ~1, intercept ~0). | y = 1.01(x) + 1.63 |
| Mean Value (Reference Method) | N/A (this is the predicate device's mean) | 17.3 ng/ml |
| Mean Value (New Device) | Expected to be close to the reference method. | 19.0 ng/ml |
| Recovery | Implied to be close to 100%. | Average 102.7% |
| Linearity | Implied to be close to 100%. | Average 96.7% |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 86 specimens
- Data Provenance: Not explicitly stated, but the specimens were sourced from "normal (including pregnancy) and disease states' populations." The country of origin is not mentioned. The study appears to be retrospective, using existing specimens for comparison against the predicate device.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is an immunoassay kit, not an image-based AI device requiring expert interpretation for ground truth. The "ground truth" for the test set was the measured PRL concentration as determined by the predicate device (Ciba Corning ACS 180 chemiluminescence test).
4. Adjudication Method
Not applicable. There was no adjudication method described as it's an immunoassay comparison study, not an expert panel review.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI device, and no MRMC study was performed.
6. Standalone Performance (Algorithm Only)
Not applicable. This is an immunoassay kit, not an AI algorithm. The performance described is the standalone performance of the kit itself in comparison to a predicate device.
7. Type of Ground Truth Used
The ground truth for the comparison study was the prolactin (PRL) concentration as determined by the predicate device, the Ciba Corning ACS 180 chemiluminescence (ICMA) test.
8. Sample Size for Training Set
The document does not mention a separate "training set." The 86 specimens were used for the clinical comparison study to demonstrate substantial equivalence against the predicate device. For an immunoassay, the "training" equivalent would be the development and calibration of the assay itself, which is not detailed in terms of sample size for that specific process.
9. How Ground Truth for Training Set Was Established
Not applicable. As this is not an AI device, there isn't a "training set" in the sense of data used to train a model. The assay itself is based on established immunoassay principles and utilizes "several different serum references of known antigen values" to generate a dose-response curve for quantification. These "known antigen values" would have been established through prior reference methods, but the specifics are not detailed here.
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KA71921
JUN 2 4 1997
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May. 21, 97
510(k) Summary
Dear Sir:
Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (IEMA) kit for the determination of prolactin (PRL) in human serum.
The proprietary name is Prolactin (PRL) ELISA and the usual name is PRL IEMA. This device classification name is - prolactin test system - product code CFT (per 21 CRF section 862.1625).
This device is substantially equivalent to the Ciba Corning ACS 180 chemiluminescence (ICMA) test, which predicates the new device.
The contact individual for this submission Is Dr. Frederick R. Jerome.
The Monobind ELISA method is based on two-site immunoassay (sandwich) technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing monoclonal blotinylated anti-PRL antibody, the enzyme-labeled anti-PRL antibody and a serum containing the native antigen (PRL), reaction results between the native antigen (PRL) and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin and biotinylated antibody. After incubation is complete, decantation or aspiration separates the bound fraction. The enzyme activity on the well is directly proportional to the native antigen (PRL) concentration. By utilizing several different serum references of known antigen values, a dose response curve can be generated from which the antigen concentration of an unknown can be ascertained.
The intended use of the device: The quantitative determination of prolactin (PRL) concentration in human serum by a microplate enzymeimmunoassay.
The technological characteristics of the new device compared to the predicate device are very similar. This includes the use of two-site immunoassay (sandwich) technology using monoclonal and polyclonal antibodies, and human serum prepared callbrators (standardized against the same international reference material). The main difference resides in the use of an enzyme tracer compared to chemiluminescence as well as magnetic particles versus streptavidin coated polystyrene wells.
Substantlal equivalency was based on clinical comparison (linear regression), using 86 specimens from normal (including pregnancy) and disease states' populations. The mean values for reference method (ICMA) and this method (microplate IEMA) are 17.3 ng/ml and 19.0 ng/ml respectively. The equation to a straight line [y= 1.01 (x) +1.63 ] and correlation coefficient (0.973) indicates good method agreement.
In addition recovery data demonstrated an average recovery of 102.7% when exogenous added prolactin was introduced into human serum specimens. Similarly, linearity studies showed an average 96.7% when specimens were diluted and compared to the dose response curve.
729 West 16" Street , Costa Mesa , CA (USA) 92627 Phone: (714) 642-4830 FAX: (714) 650-8459
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JUN 2 4 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Frederick R. Jerome Monobind, Inc. 729 West 16th Street Costa Mesa, California 92627
Re: K971921 Prolactin (PRL) Hormone Microplate ELISA Regulatory Class: I Product Code: CFT Dated: May 22, 1997 May 23, 1997 Received:
Dear Dr. Jerome:
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 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 (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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FPA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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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 lefter 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 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 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 qeneral 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 Litman
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
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Indications for Use Statement
510(k) Number (if known): K971921
Device Name: Prolactin (Prl) Hormone ELISA
The Quantitative Determination of Prolactin Hormone Concentration in Human Serum by a Microplate Immunoenzymometric assay. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or the hypothalamus portion of the brain.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
vision Sign-Off) Division of Clinical Laboratory S10(k) Number
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Folmat 1-2-96)
§ 862.1625 Prolactin (lactogen) test system.
(a)
Identification. A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.