(15 days)
The DPC IMMULITE 1000 is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE. The intent of the system is to impart the same automation to the array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE. The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the IMMULITE predicate system.
The DPC IMMULITE 1000 product is essentially an upgrade of the current IMMULITE system. All of the current functionality will be retained; however, the system will be enhanced with regard to the user interface, casework, and system footprint. The operating system will be changed to a Windows 2000 environment. In addition, the system will be remodeled to give the IMMULITE a more "modern" look and feel to be part of the "IMMULITE Family". Finally, the total system footprint will be decreased by such mechanisms as integrating the PC into the architecture of the system and provide a defined area for storing bulk materials (i.e., waste, water, and, probe wash).
The provided text is a 510(k) summary for the IMMULITE® 1000 Automated Immunoassay Analyzer, which is essentially an upgrade of an existing system (IMMULITE). The document states that the modifications do not change the indications for use or the intended use, and the device is intended to assay the same broad range of analytes in patient samples as the predicate IMMULITE.
However, the 510(k) summary does not contain the detailed information required to answer many of the questions asked. This type of regulatory submission often focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive de novo study details with specific acceptance criteria, sample sizes for test and training sets, expert qualifications, or comparative effectiveness studies.
Here's an analysis based on the provided text, highlighting what's available and what's missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, precision, limits of detection for various analytes) or report detailed device performance results against these criteria. It focuses on the equivalence to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Since this is an automated immunoassay analyzer, the "ground truth" would typically come from reference methods or established clinical diagnostics, not from expert consensus interpreting images or other qualitative data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for qualitative assessments, often in imaging studies where multiple readers interpret cases. For an immunoassay analyzer measuring analytes, performance is usually assessed quantitatively against reference standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study is not mentioned. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret data. The IMMULITE 1000 is an automated immunoassay analyzer, not a diagnostic imaging AI system that "assists" human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The IMMULITE 1000 is inherently a "standalone" automated system in the sense that it performs the immunoassay measurements without continuous human intervention during the assay process. The results are generated by the instrument. However, the document does not detail specific "standalone performance studies" in a structured way that would be typical for a novel AI algorithm's standalone evaluation. Instead, it implies that the performance is demonstrated to be equivalent to the predicate IMMULITE system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for an immunoassay analyzer would typically be established by:
- Reference Methods: Using established, highly accurate laboratory methods for analyte measurement.
- Certified Reference Materials/Standards: Calibrating and verifying performance against materials with known analyte concentrations.
- Comparison to Predicate Device: Given that this is a 510(k) for an upgrade, the primary "ground truth" implicitly relies on the proven performance of the predicate IMMULITE system for the broad range of analytes. The document states, "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for the IMMULITE 1000 Analyzer," implying that the data primarily demonstrated equivalence.
8. The sample size for the training set
This information is not provided. Immunoassay analyzers are not "trained" in the same way machine learning models are. Their "training" or calibration involves using specific calibrators and controls to establish a standard curve or reference points for measurement, which is a different concept than a "training set" for AI.
9. How the ground truth for the training set was established
As mentioned above, the concept of a "training set" and its "ground truth" in the context of machine learning, is not directly applicable to this device in the way implied by the question. The "ground truth" for the calibration and verification of an immunoassay system would be established using certified calibrators and controls with known values, or by comparison to established reference methods and the predicate device. The document does not elaborate on these details.
Summary of what the document does communicate:
- Acceptance Criteria (Implied): The primary acceptance criterion for this 510(k) appears to be substantial equivalence to the predicate IMMULITE system. The device needs to produce "safe and effective performance" for the "same broad range of analytes in patient samples" as the IMMULITE.
- Study Proving Acceptance Criteria: The document states that "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for the IMMULITE 1000 Analyzer." This implies that studies were conducted to demonstrate that the IMMULITE 1000 performs comparably to the original IMMULITE system across its intended applications. These studies would typically involve method comparison, precision, linearity, and interference studies, but the specific results and methodologies are not detailed in this public 510(k) summary.
- Changes to the Device: The modifications are primarily focused on the user interface, casework, system footprint, and operating system (Windows 2000 environment), not fundamental changes to the underlying immunoassay technology (14-inch polystyrene antibody coated beads, alkaline phosphatase labeled antibody/antigen, chemiluminescent detection). This reinforces the focus on demonstrating equivalence rather than proving novel performance.
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AUG 2 1 2002
510(k) Summary of 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 StreetLos Angeles, California 90045-5597 | |
| Telephone Number:Facsimile Number: | (310) 645-8200(310) 645-9999 | |
| Contact Person: | Edward M. Levine, Ph.D.Director, Clinical Affairs | |
| Date of Preparation: | August 5, 2002 | |
| Device Name:Trade: | IMMULITE® 1000 | |
| Catalog Number: | IMILITE | |
| CFR: | A discrete photometric chemistry analyzer for clinical useis a device intended to duplicate manual analyticalprocedures by performing automatically various steps suchas pipetting, preparing filtrates, heating, and measuringcolor intensity. This device is intended for use inconjunction with certain materials to measure a variety ofanalytes. Different models of the device incorporate variousinstrumentation such as microanalysis apparatus, doublebeam, single, or dual channel photometers, and bichromatic2-wavelength photometers. Some models of the device mayinclude reagent-containing components that may also serveas reaction units. | |
| Common | Discrete photometric chemistry analyzer for clinical use. | |
| Classification: | Class I device, JJE (21 CFR 862.1260) | |
| Panel: | Clinical Chemistry | |
| Manufacturer: | Corporate Headquarters:Diagnostic Products Corp.5700 West 96th StreetLos Angeles, CA 90045 | Instrument Manufacturer:DPC Instrument Systems Div.62 Flanders Bartley RoadFlanders, NJ 07836(Formerly DPC Cirrus Inc.) |
| Establishment Registration | ||
| Number: | DPC Headquarters Registration Number is 2017183 andDPC Instrument Systems Division Registration Number is2247117 | |
| Substantially | ||
| EquivalentPredicate Device: | IMMULITE (K905215) | |
| Description of Device: | IMMULITE 1000 Automated Immunoassay Analyzer |
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Intended Use of the Device:
These modifications do not change the indications for use, nor the intended use from the IMMULITE to the IMMULITE 1000. The DPC IMMULITE 1000 is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE. The intent of the system is to impart the same automation to the array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE. The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the IMMULITE predicate system.
Product Description:
The DPC IMMULITE 1000 product is essentially an upgrade of the current IMMULITE system. All of the current functionality will be retained; however, the system will be enhanced with regard to the user interface, casework, and system footprint. The operating system will be changed to a Windows 2000 environment. In addition, the system will be remodeled to give the IMMULITE a more "modern" look and feel to be part of the "IMMULITE Family". Finally, the total system footprint will be decreased by such mechanisms as integrating the PC into the architecture of the system and provide a defined area for storing bulk materials (i.e., waste, water, and, probe wash).
Technology:
The IMMULITE 1000 uses 14 inch polystyrene antibody coated beads and assay specific antibody or antigen labeled with alkaline phosphatase. The chemiluminescent detection system is a phosphate ester stabilized dioxetane. Cleavage of the phosphate ester by alkaline phosphatase results in the decomposition of the dioxetane and the emission of photons, which are quantified by a luminometer and are proportional to the quantity of analyte present.
Conclusion:
The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for the IMMULITE 1000 Analyzer.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 1 2002
Edward M. Levine, Ph.D. Director, Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597
K022603 Trade/Device Name: IMMULITE® 1000 Automated Immunoassay Analyzer Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW; JJE; DHA; LGC; DCN; LPS; JMF; CFP; DHB; CEP; LAF; DDR; LTK; JFH; DLZ; DIP; JLS; CFT; LTJ; JMM; JLW; LFX; CEE; KLS; MSW; JHR; CDP; KLI; CDZ; LGD; MMI; JHX; CGI; LEG; CDD CKG; LOJ; DFJ; DGO; DKZ; JZO; MOI; LDJ; KLT; DHX; LFZ; DIO; CGR; JKD; JKC; LFM; KXT; GGT; CHP; JMG; CGN; CEC; CGJ; CFL; LYR; JZG Dated: August 5, 2002 Received: August 6, 2002
Dear Dr. Levine:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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/dsmaldsmamain.html".
Sincerely yours,
Steven Putman
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): HO3 Hoo3 IMMULITE® 1000 Automated Immunoassay Analyzer Device Name:
Indications For Use: The DPC IMMULITE 1000 is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE. The intent of the system is to impart the same automation to the array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE. The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the IMMULITE predicate system.
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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number -િત Over-The-Counter Use . OR (Per 21 CFR 801 109)
(Optional Format 1-2-96)
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.