(56 days)
DPC's IMMULITE® HCG
Not Found
No
The description details a standard immunoassay technology and does not mention any AI or ML components.
No.
The device is described as an "in vitro use" assay intended "as an aid in the detection of pregnancy," which means it is for diagnostic purposes and not for treating a condition.
Yes
The device is described as an "aid in the detection of pregnancy," which is a diagnostic purpose. It quantitatively measures HCG in biological samples to help determine a medical condition (pregnancy).
No
The device is an in vitro diagnostic (IVD) assay that utilizes chemical reactions and a physical analyzer (IMMULITE Automated Analyzer) to measure HCG. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is "intended strictly for in vitro use as an aid in the detection of pregnancy." The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details a laboratory assay that analyzes a biological sample (serum, Heparinized or EDTA plasma) using chemical and immunological reactions to measure a substance (HCG). This process is performed outside of the patient's body.
- Measurement of a Biomarker: The device measures human chorionic gonadotropin (HCG), which is a biomarker found in biological fluids and used to indicate a physiological state (pregnancy). This is a common function of IVDs.
N/A
Intended Use / Indications for Use
IMMULITE® Turbo HCG is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of human chorionic gonadotropin (HCG) in serum, and Heparinized or EDTA plasma. It is intended strictly for in vitro use as an aid in the detection of pregnancy.
Product codes
DHA
Device Description
IMMULITE® Turbo HCG is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer.
IMMULITE Turbo HCG is a solid-phase, two-site chemiluminescent immunometric assay. The solid phase, a polystyrene bead enclosed within an IMMULITE Test Unit, coated with a monoclonal antibody specific for HCG beta subunit. While the patient sample and alkaline phospatase-conjugated polyclonal antibody are incubated for approximately 6 minutes at 37°C In the Test Unit with intermittent agitation, HCG in the sample is bound to form an antibody sandwich complex. Unbound conjugate is then removed by a centrifugal wash, after which substrate is added and the Test Unit is incubated for a further 4 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of HCG in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
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Summary of Performance Studies
Method Comparison: The IMMULITE Turbo HCG procedure was compared to DPC's IMMULITE HCG on 60 patient serum samples, with HCG concentrations ranging from approximately 8 mIU/mL to over 3,000 mIUmL. Linear regression analysis yielded the following statistics: (IMMULITE Turbo) = 1.0 (IMMULITE) = 12 mIU/mL r = 0.999. Means: 439 mIU/mL (IMMULITE Turbo), 445 mIU/mL (IMMULITE).
Key Metrics
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Predicate Device(s)
DPC's IMMULITE® HCG
Reference Device(s)
Not Found
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
'JAN 2 8 2000
510 (k) Summary Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Name: | Diagnostic Products Corporation |
|---|---|
| Address: | 5700 West 96th Street |
| Los Angeles, California 90045-5597 | |
| Telephone Number: | (310) 645-8200 |
| Facsimile Number: | (310) 645-9999 |
| Contact Person: | Edward M. Levine, Ph.D. |
| Director of Clinical Affairs | |
| Date of Preparation: | December 1, 1999 |
| Device Name: | |
| Trade: | IMMULITE® Turbo HCG |
| Catalog Number: | LSKCG1 (100 tests), LSKCG5 (500 tests) |
| Common: | Reagent system for the determination of human chorionic |
| gonadotropin in serum or plasma. | |
| Classification: | Class II device, DHA (21 CFR 862.1155) |
| Panel: | Clinical Chemistry |
| Manufacturer: | Diagnostic Products Corporation (DPC) |
| 5700 West 96th Street | |
| Los Angeles, CA 90045-5597 | |
| Establishment | |
| Registration #: | DPC's establishment Registration No. is 2017183 |
| Substantially Equivalent | |
| Predicate Device: | DPC's IMMULITE® HCG |
| Description of Device: | IMMULITE® Turbo HCG is a two-site chemiluminescent enzyme |
| immunometric assay for use with the IMMULITE® Automated | |
| Analyzer. | |
| Intended Use of the | |
| Device: | IMMULITE® Turbo HCG is a solid-phase, two-site |
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chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer and designed for the quantitative measurement of HCG in serum or plasma. It is intended strictly for in vitro use as an aid in the detection of pregnancy.
Technology Comparison:
Provided for the reviewer is an explanation of DPC's IMMULITE Turbo HCG and IMMULITE HCG Kit technology. This section does not contain any new information for a reviewer who is familiar with the DPC IMMULITE System based upon the review of previous IMMULITE and IMMULITE Turbo assay submissions.
IMMULITE Turbo HCG is a solid-phase, two-site chemiluminescent immunometric assay. The solid phase, a polystyrene bead enclosed within an IMMULITE Test Unit, coated with a monoclonal antibody specific for HCG beta subunit. While the patient sample and alkaline phospatase-conjugated polyclonal antibody are incubated for approximately 6 minutes at 37°C In the Test Unit with intermittent agitation, HCG in the sample is bound to form an antibody sandwich complex. Unbound conjugate is then removed by a centrifugal wash, after which substrate is added and the Test Unit is incubated for a further 4 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of HCG in the sample.
IMMULITE HCG is a solid-phase, two-site chemiluminescent immunometric assay. The solid phase, a polystyrene bead enclosed within an IMMULITE Test Unit, coated with a monoclonal antibody specific for HCG beta subunit. While the patient sample and alkaline phospataseconjugated polyclonal antibody are incubated for approximately 30 minutes at 37℃ In the Test Unit with intermittent agitation. HCG in the sample is bound to form an antibody sandwich complex. Unbound conjugate is then removed by a centrifugal wash, after which substrate is added and the Test Unit is incubated for a further 5 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of HCG in the sample.
2
Performance Equivalence:
Diagnostic Products Corporation asserts that IMMULITE Turbo HCG assay produces substantially equivalent results to other commercially marketed HCG assays, such as the IMMULITE HCG Kit. Each product is designed for the quantitative measurement of HCG. Each product is intended strictly for in vitro diagnostic use as an aid in the detection of pregnancy.
Method Comparison:
The IMMULITE Turbo HCG procedure was compared to DPC's IMMULITE HCG on 60 patient serum samples, with HCG concentrations ranging from approximately 8 mIU/mL to over 3,000 mIUmL. Linear regression analysis yielded the following statistics:
(IMMULITE Turbo) = 1.0 (IMMULITE) = 12 mIU/mL r = 0.999
439 mIU/mL (IMMULITE Turbo) Means: 445 mIU/mL (IMMULITE)
Conclusion:
The data presented in this summary of safety and effectiveness is the data that the Food and Drug File data problemed in and baninaly of bareantial equivalence for IMMULITE® Turbo HCG.
Eduard Heuss
Edward M. Levine, Ph.D. Director of Clinical Affairs
12/1/99
Date
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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 eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 8 2000
Edward M. Levine, Ph.D. Director, Clinical Affairs Diagnostics Products Corporation 5700 West 96th Street Los Angeles. California 90045-5597
Re: K994085 Trade Name: IMMULITE® Turbo HCG Regulatory Class: II Product Code: DHA Dated: December 1, 1999 Received: December 3, 1999
Dear Dr. Levine:
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 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). 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) 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 Register. 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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This letter 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" (21CFR 807.97). Other general 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/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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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510(k) Number (if known): Device Name:_IMMULITE® Turbo HCG
Indications For Use:
IMMULITE Turbo HCG is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of human chorionic gonadotropin (HCG) in serum, and Heparinized or EDTA plasma. It is intended strictly for in vitro use as an aid in the detection of pregnancy.
Dean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994065
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-