(67 days)
No
The summary describes a standard immunoassay technology (MEIA) for quantitative determination of a hormone. There is no mention of AI, ML, image processing, or any data-driven algorithms beyond standard statistical analysis for performance evaluation.
No.
This device is an in vitro diagnostic (IVD) test for quantitative determination of parathyroid hormone, intended to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is intended for use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia." This directly indicates its role as a diagnostic device.
No
The device description clearly states it is a Microparticle Enzyme Immunoassay (MEIA) and uses antibodies, indicating it is a laboratory assay kit with physical components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "for the in vitro quantitative determination of intact human parathyroid hormone (I PTH) in human serum or plasma". The phrase "in vitro" is a key indicator of an IVD. It also mentions its use as an "aid in the differential diagnosis of hypercalcemia and hypocalcemia," which is a diagnostic purpose.
- Device Description: The description details a "Microparticle Enzyme Immunoassay (MEIA)" which is a laboratory technique used to measure substances in biological samples outside of the body.
- Input Imaging Modality: It is listed as "Not Applicable," which is consistent with a device that analyzes biological samples rather than images.
- Anatomical Site: It is listed as "Not Applicable," further indicating that it does not interact directly with a patient's anatomy.
- Performance Studies: The performance studies describe the analysis of "samples" and correlation with a "predicate device," which are typical characteristics of IVD validation.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
AxSYM® Intact PTH is a Microparticle Enzyme Immunoassay (MEIA) for the in vitro quantitative determination of intact human parathyroid hormone (I PTH) in human serum or plasma on the AxSYM® system. The AxSYM® I PTH assay is intended for use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
Product codes
CEW, JIT, JIX
Device Description
AxSYM I PTH is based on the Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM I PTH reagents and sample are pipetted into various wells of a Reaction Vessel (RV). The RV is immediately transferred into the Processing Center. An aliquot of the reaction mixture containing the antibody-antigen complex bound to the microparticles is transferred to the matrix cell. The microparticles bind irreversibly to the glass fiber matrix. The matrix cell is washed with the TRIS Wash Buffer. The Anti-PTH: Biotin Conjugate is dispensed onto the matrix cell and binds with the antibody-antigen complex. The matrix cell is washed to remove unbound materials. The Anti-Biotin: Alkaline Phosphatase Conjugate is then dispensed onto the matrix cell and binds with the biotinylated antibody-antigen complex. The matrix cell is washed to remove unbound materials. The substrate, 4-Methylumbelliferyl Phosphate, is added to the matrix cell and the fluorescent product is measured by the MEIA optical assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Method correlation between the AxSYM® I PTH and the predicate device was examined using 120 samples. The resulting regression equation was determined to be: [AxSYM® I PTH] = 0.99 [DSL ACTIVE™ I PTH IRMA] + 10.0 r = 0.97 p
§ 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS 4.0
Diagnostic Systems Laboratories, Inc. Submitter: 445 Medical Center Boulevard Webster, Texas 77598 Phone: 281-332-9678 FDA Registration # 1628193
Contact: Carroll Potts Manager of Regulatory Affairs Office: (281) 332-9678 Fax: (281) 338-1895 cpotts@dslabs.com
| Date of Summary: | May 22, 2002 |
|---|---|
| Device Trade Name: | AxSYM Intact PTH |
| Regulation Cite: | 21CFR862.1545 |
| Classification Name: | Parathyroid Hormone |
| Analyte Code and Name: | (CEW) Parathyroid Hormone Test System |
| Regulatory Class: | II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 to provide sufficient detail to understand the basis for a determination of substantial equivalence.
8020945 The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
Test Description: 4.1
Parathyroid hormone (PTH, parathyrin) is synthesized as a pre-pro hormone 4.1.1 by the chief cells of the parathyroid glands [1,2]. In normal physiology, PTH levels increase in response to decreased serum calcium and decrease in response to increased serum calcium resulting in a close inverse relationship between PTH and calcium concentrations [1,6]. Abnormal PTH levels can thus be detected by examining this interrelationship. Concurrent increases in PTH and calcium occur in the various forms of hyperparathyroidism, including multiple endocrine neoplasia (MEN) types I and II, parathyroid turnors, and idiopathic hyperparathyroidism [6,7]. Concurrent declines in calcium and PTH occur in the various forms of primary hypoparathyroidism and in disorders affecting PTH secretion, such as hypo- or hyper-magnesemia [8]. Abnormally low calcium levels in the presence of extremely elevated PTH levels can occur in a group of genetic disorders called pseudohypoparathyroidism [9]. Abnormally high calcium levels in the presence of low or normal PTH levels are characteristic of malignancy-associated hypercalcemia secondary to PTH-related peptide (PTHrP) production [10]. Abnormal concentrations and/or actions of PTH with essentially normal serum calcium levels may also occur, e.g. in renal osteodystrophy [11].
NOTE: The bibliography notations used make reference to the Bibliography Section at the end of the AxSYM I PTH Package Insert.
1
Immunoassays for I-PTH and its two major metabolic fragments have been 4.1.2 developed. Clinical investigations indicate that the diagnostic sensitivities of the Nterminal and C-terminal assays are limited, possibly due in part to variable concentrations of minor fragments and the performance characteristics of the assays [1,4]. Selective measurement of mainly I PTH has theoretical advantages since it may be more reflective of biologically active PTH production and action.
The AxSYM® I PTH assay uses paired monoclonal and polyclonal 4.1.3 antibodies, each reactive with epitopes in the N-terminal portion of intact human PTH (1-84). The polyclonal antibody is biotin labeled. I PTH in the sample serves to bridge the two antibodies.
4.2 Principle Of The Test:
AxSYM I PTH is based on the Microparticle Enzyme Immunoassay 4.2.1 (MEIA) technology.
The AxSYM I PTH reagents and sample are pipetted in the following sequence:
4.2.2 SAMPLING
- Sample and all AxSYM® I PTH Reagents required for one test are pipetted by . the sampling probe into various wells of a Reaction Vessel (RV).
The RV is immediately transferred into the Processing enter. Further pipetting is done in the Processing Center by the Processing Probe.
PROCESSING 4.2.3
- An aliquot of the reaction mixture containing the antibody-antigen complex . bound to the microparticles is transferred to the matrix cell. The microparticles bind irreversibly to the glass fiber matrix..
- The matrix cell is washed with the TRIS Wash Buffer. ●
- The Anti-PTH: Biotin Conjugate is dispensed onto the matrix cell and binds . with the antibody-antigen complex.
- The matrix cell is washed to remove unbound materials. .
- The Anti-Biotin: Alkaline Phosphatase Conjugate is then dispensed onto the . matrix cell and binds with the biotinylated antibody-antigen complex.
- The matrix cell is washed to remove unbound materials. .
- The substrate, 4-Methylumbelliferyl Phosphate, is added to the matrix cell and . the fluorescent product is measured by the MEIA optical assembly.
2
4.3 Intended Use:
AxSYM® Intact PTH is a Microparticle Enzyme Immunoassay (MEIA) for the in vitro quantitative determination of intact human parathyroid hormone (I PTH) in human serum or plasma on the AxSYM® system. The AxSYM® I PTH assay is intended for use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
4.4 Substantial Equivalence:
The AxSYM® Intact PTH assay is substantially equivalent to another 4.4.1 device marketed in the United States. We claim equivalence to the DSL-8000 ACTIVE™ Intact PTH IRMA (K896294).
- To demonstrate substantial equivalence between the two assays, serum and 4.4.2 plasma samples were assayed using both methods. Method correlation between the AxSYM® I PTH and the predicate device was examined using 120 samples. The resulting regression equation was determined to be:
[AxSYM® I PTH] = 0.99 [DSL ACTIVE™ I PTH IRMA] + 10.0 r = 0.97 p in vitro quantitative
determination of intact human
parathyroid hormone (I PTH)
in human serum or plasma on
the AxSYM® system | for the quantitative
measurement of Intact PTH (I-
PTH) in serum or plasma. |
| Indication for Use | an aid in the differential
diagnosis of hypercalcemia and
hypocalcemia | None stated in package insert |
| Sample type | Human serum or plasma | Human serum or plasma |
| Sample required | 185 µL | 200 µL |
| Dynamic Range | 0 - 2000 pg/mL | 0 - 2000 pg/mL |
| Expected Values | 8 - 57.8 pg/mL | 9 - 55 pg/mL |
| Traceability | Traceable to DSL I PTH
IRMA | Traceable to Nichols I PTH
Assay |
The following table compares the differences between the AxSYM I PTH Differences: assay and the predicate device:
| Feature | AxSYM I PTH | Predicate Device (K896294) |
|---|---|---|
| Assay Technology | Microparticle Enzyme | |
| Immunoassay (MEIA) | ||
| employing the "sandwich" | ||
| principle | Immunoradiometric Assay | |
| (IRMA) employing the | ||
| "sandwich" principle | ||
| Instrument | AxSYM Immunoassay | |
| Analyzer | Gamma Counter |
4
Performance Characteristics:
The following table compares the assay performance characteristics between the
| Characteristics | AxSYM® Intact PTH | Predicate Device (K896294) |
|---|---|---|
| Precision (Within | ||
| Run) | Level I (35.3 pg/mL): 5.9 % CV | Level I (13.0 pg/mL): 3.1 % CV |
| Level II (202.9 pg/mL): 6.2 % CV | Level II (23.0 pg/mL): 3.5 % CV | |
| Level III (649.7 pg/mL): 6.5 % CV | Level III (476 pg/mL): 1.9 % CV | |
| Precision (Inter) | Level I (35.3 pg/mL): 9.4 % CV | Level I (13.0 pg/mL): 3.1 % CV |
| Level II (202.9 pg/mL): 8.1 % CV | Level II (23.0 pg/mL): 5.2 % CV | |
| Level III (649.7 pg/mL): 8.8 % CV | Level III (472.0 pg/mL): 2.6 % CV | |
| Linearity (Mean ± SD) | 93.8 ± 8.9 % | 94.2 ± 10.5 % |
| Recovery (Mean ± SD) | 95.3 ± 8.9 % | 97.7 ± 5.2 % |
| Analytical Sensitivity | ≤ 2.0 pg/mL I PTH | 6.0 pg/mL I PTH |
| Specificity | No detection of human PTH fragments | |
| 53-84, 44-68 and 39-84 | No detection of human PTH | |
| fragments 53-84, 44-68 and 39-84 | ||
| Interference | Bilirubin (20 mg/dL): |