(203 days)
ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
ST AIA-PACK ACTH Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers
ST AIA-PACK ACTH Control Set is designed for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers
The ST AIA-PACK ACTH is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK ACTH test cups. ACTH present in the test sample is bound with anti-ACTH goat polyclonal antibody immobilized on magnetic beads and enzyme-labeled anti-ACTH goat polyclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled anti-ACTH goat polyclonal antibody and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The enzyme alkaline phosphatase causes oxidation of 4MUP to 4MU. 4MU is excited at 365 nm and comes to ground state at 448 nm releasing florescent energy. The amount of florescent energy is measured by the detector.
The amount of enzyme-labeled anti-ACTH goat polyclonal antibody that binds to the beads is directly proportional to the ACTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
The ST AIA-PACK ACTH assay is designed to quantitatively measure adrenocorticotropic hormone (ACTH) in human EDTA plasma for in vitro diagnostic use. The following information details the acceptance criteria and the studies conducted to demonstrate the device's performance, as outlined in the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Internal/Guideline) | Reported Device Performance |
|---|---|---|
| Precision (Within-Run CV%) | Not explicitly stated as acceptance criteria, but within typically acceptable ranges for immunoassays. | Reagent Set #1: Level A: 3.1%, Level B: 2.1%, Level C: 1.5%Reagent Set #2: Level A: 2.8%, Level B: 2.1%, Level C: 2.1%Reagent Set #3: Level A: 2.2%, Level B: 2.3%, Level C: 2.2% |
| Precision (Total CV%) | Not explicitly stated as acceptance criteria, but within typically acceptable ranges for immunoassays. | Reagent Set #1: Level A: 3.3%, Level B: 2.5%, Level C: 2.2%Reagent Set #2: Level A: 4.2%, Level B: 3.8%, Level C: 3.4%Reagent Set #3: Level A: 2.5%, Level B: 2.8%, Level C: 2.2% |
| Linearity | Repeatability CV% <= 10% | Repeatability CV% met the criterion of <= 10%. Linear from 2.0 to 2,000 pg/mL. |
| Correlation (Slope) | Not explicitly stated as acceptance criteria, but compared to predicate. | Deming: 1.10 (95% CI: 1.075 to 1.116)Regular: 1.09 (95% CI: 1.067 to 1.107) |
| Correlation (Intercept) | Not explicitly stated as acceptance criteria, but compared to predicate. | Deming: -0.84 (95% CI: -8.921 to 7.234)Regular: 0.76 (95% CI: -7.305 to 8.817) |
| Correlation Coefficient (R) | Not explicitly stated as acceptance criteria, but compared to predicate. | 0.993 |
| Bias | Not explicitly stated as acceptance criteria, but reported for comparison. | All samples: 17.8 pg/mLAt medical decision point (7.4-64.3 pg/mL): 4.87 pg/mLAt 7.73 pg/mL: -0.87 pg/mLAt 64.97 pg/mL: -17.93 pg/mL |
| Limit of Quantitation (LoQ) | Not explicitly stated as an acceptance criterion for the study, but the assay low claim is 2.0 pg/mL. | Calculated LoQ: 1.2 pg/mL (Conservative claim of 2.0 pg/mL in event of lot-to-lot variability) |
| Limit of Detection (LoD) | Not explicitly stated as an acceptance criterion for the study. | 0.7 pg/mL |
| Limit of Blank (LoB) | Not explicitly stated as an acceptance criterion for the study. | 0.5 pg/mL |
| Interference | Recovery within 100 ± 10% | No interference from: Hemoglobin (up to 440 mg/dL), Conjugated bilirubin (up to 19 mg/dL), Free bilirubin (up to 17 mg/dL), Lipemia (up to 1,600 mg/dL triglycerides), Ascorbic acid (up to 20 mg/dL), EDTA.2K (up to 7 mg/mL), Human albumin (up to 5.0 g/dL), Rheumatoid factor (up to 500 IU/mL), Heparin (up to 50 U/mL), Acetominaphen (up to 20 mg/L), Acetylsalicylic acid (up to 300 mg/L), Ampicillin (up to 200 mg/L), Ibuprofen (up to 50 mg/L), Theophylline (up to 10 mg/L). |
| Specificity | Recovery within 90 - 110% | ACTH 1-10: 100-102% recovery at various concentrations.ACTH 11-24: 98-99% recovery at various concentrations.Beta-MSH: 95-100% recovery at various concentrations.Beta-Endorphin: 97-100% recovery at various concentrations. |
2. Sample Size Used for the Test Set and Data Provenance:
- Precision Study: Three levels of unaltered EDTA plasma specimens were used. For each level, measurements were taken across 3 reagent lots, 3 analyzers, 2 replicates per run, 2 times a day for 20 non-consecutive days, totaling 80 determinants per reagent set/analyzer combination for precision evaluation. The exact number of individual "samples" (patient specimens) is not explicitly stated beyond "three levels of unaltered EDTA plasma specimens."
- Linearity Study: The number of samples/specimens is not explicitly stated. The study aimed to demonstrate linearity over the range of 2.0 to 2,000 pg/mL using the EP6-A CLSI protocol.
- Correlation Study: A total of 160 EDTA plasma specimens were used (154 unaltered and 6 altered specimens). The data provenance is not explicitly stated (e.g., country of origin). The study used a combination of fresh and frozen specimens.
- LoD/LoQ Study: Not specified, but based on CLSI Protocol EP17-A.
- Interference Study: Not specified, but various interfering substances were added to samples.
- Specificity Study: Not specified, but "Control" (presumed matrix without ACTH fragments) and samples spiked with different ACTH fragments were used.
The data provenance (country of origin) is not provided in the summary. The studies appear to be retrospective in the sense that existing plasma samples were used, or samples were created with specific characteristics for testing (e.g., altered specimens for correlation, spiked samples for interference/specificity).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This device is an in vitro diagnostic assay that measures a quantitative biomarker (ACTH concentration). The concept of "ground truth" for the test set is established through reference methods and clinical guidelines, rather than expert human interpretation of results like in imaging studies.
- For the Correlation Study, the predicate device (Roche Elecsys ACTH Immunoassay on the MODULAR ANALYTICS E170 analyzer) served as the comparative "reference" against which the new device's measurements were assessed for agreement. The "ground truth" for the quantitative values of ACTH in the 160 specimens would have been the values reported by the predicate device (or potentially a definitive reference method, though not stated).
- For other studies like Precision, Linearity, LoD/LoQ: The "ground truth" is defined by the expected performance characteristics based on established analytical standards (CLSI protocols) and the intrinsic properties of the assay and the analyte itself.
Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications is not directly applicable in the same way it would be for, for example, a diagnostic imaging study where radiologists interpret images.
4. Adjudication Method for the Test Set:
Not applicable in the usual sense for this type of quantitative biochemical assay. The "ground truth" is established through the measurement by a comparative method (predicate device) and adherence to CLSI statistical protocols for analytical performance characteristics. There is no mention of a human adjudication process for resolving discrepancies in quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is being evaluated. The ST AIA-PACK ACTH is a laboratory assay for quantitative measurement, and its performance is assessed through analytical validation studies (precision, linearity, correlation, etc.) as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies presented (Precision, Linearity, Correlation, LoD/LoQ, Interference, Specificity) represent the standalone performance of the ST AIA-PACK ACTH assay system. The device produces a quantitative measurement of ACTH in a sample, and these studies assess the accuracy, reproducibility, and reliability of those measurements as produced by the instrument and reagent system, without human interpretation of the primary output (the ACTH concentration value). While a human ultimately interprets the clinical significance of the numerical ACTH result, the performance metrics described here are purely analytical/algorithm-only.
7. The Type of Ground Truth Used:
The "ground truth" in these studies is primarily based on:
- Comparator Method (Predicate Device): For the correlation and method comparison study, the Elecsys ACTH Immunoassay on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 served as the reference method. The agreement between the new device's readings and the predicate device's readings was assessed.
- Known Concentrations/Spiked Samples: For linearity, LoD/LoQ, interference, and specificity studies, samples were likely prepared with known concentrations of ACTH (or interfering substances/fragments) or serially diluted to establish the expected "true" value for evaluation.
- Adherence to CLSI Protocols: These protocols provide a framework for establishing acceptable analytical performance, and meeting these statistical and methodological guidelines serves as a form of "ground truth" for demonstrating device competency.
8. The Sample Size for the Training Set:
This information is not provided in the 510(k) summary. Given that this is a biochemical immunoassay (fluorescence-based sandwich immunoassay), it's unlikely that a "training set" in the context of machine learning algorithms (which often have large training datasets) was used in the same way. Immunoassays are developed through chemical and biological engineering, and their operating parameters are typically optimized through experimental design and iterative changes to reagents and protocols, rather than a data-driven "training" phase.
9. How the Ground Truth for the Training Set Was Established:
As discussed in point 8, the concept of a "training set" and associated "ground truth" for a biochemical immunoassay is not applicable in the typical sense of AI/machine learning. The "development" and "optimization" of such an assay involve:
- Selection and Development of Reagents: Antibodies, enzymes, fluorogenic substrates, and beads are chosen and optimized for specificity and sensitivity.
- Calibration Standards: Known concentrations of ACTH (gravimetrically prepared standards like ACTH (Human, 1-39) Bachem AG: code. H-1160) are used to establish the standard curve, which is the basis for calculating unknown sample concentrations. These standards effectively define the "ground truth" for the quantitative measurement.
- Quality Control Materials: Known-value control samples are used to monitor the assay's performance over time.
These elements constitute how the assay's ability to measure ACTH accurately is "established" during its development, rather than through a machine learning training process.
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K 111/335
DEC - 1 2011
510(k) Summary
ST AIA-PACK ACTH
Date:
Submitter:
Contact Person: ﻣﺴ ﺎ
Device Name:
Classification:
Device Name:
Classification
Device Name:
Classification
Predicate Device:
August 16, 2011
Tosoh Bioscience, Inc 3600 Gantz Road Grove City, OH 43123
Judith K. Ogden Director, New Business & Technical Development 6000 Shoreline Ct., Ste. 101 South San Francisco, CA 94080 Phone: 650-636-8112 Fax: 650-636-8113 Email: Judy.Ogden@tosoh.com
ST AIA-PACK ACTH
Class II CKG Clinical Chemistry 21 CFR 862.1025
ST AIA-PACK ACTH Calibrator Set
Class II JIT Clinical Chemistry 21 CFR 862.1150
AIA-PACK ACTH Control Set
Class I אר Clinical Chemistry 21 CFR 862.1660
k 060585 Roche Diagnostics Elecsys ACTH Immunoassay Elecsys ACTH CalSet
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510(k) Summary
ST AIA-PACK ACTH
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Device Description:
The ST AIA-PACK ACTH is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK ACTH test cups. ACTH present in the test sample is bound with anti-ACTH goat polyclonal antibody immobilized on magnetic beads and enzyme-labeled anti-ACTH goat polyclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled anti-ACTH goat polyclonal antibody and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The enzyme alkaline phosphatase causes oxidation of 4MUP to 4MU. 4MU is excited at 365 nm and comes to ground state at 448 nm releasing florescent energy. The amount of florescent energy is measured by the detector.
The amount of enzyme-labeled anti-ACTH goat polyclonal antibody that binds to the beads is directly proportional to the ACTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
| The following products are required to use the ST AIA-PACK ACTH | P/N 025221: |
|---|---|
| ST AIA-PACK ACTH Calibrator Set | P/N 025321 |
| ST AIA-PACK ACTH Sample Diluting Solution | P/N 025521 |
| AIA-PACK ACTH Control Set | P/N 025421 |
Device Intended Use:
ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are useful in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
ST AIA-PACK ACTH Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK ACTH assay on Tosoh AIA Systems Analyzers.
The AIA-PACK ACTH Control Set is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK ACTH Assay.
ST AIA-PACK ACTH
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Substantial Equivalence:
Comparison between the Tosoh ST AIA-PACK ACTH and the Roche Diagnostics Elecsys ACTH Immunoassay
Similarities:
| Item | Device | Predicate |
|---|---|---|
| ST AIA-PACK ACTH | Elecsys ACTH | |
| Intended Use | ST AIA-PACK ACTH isdesigned for IN VITRODIAGNOSTIC USE ONLYfor the quantitativemeasurement ofAdrenocorticotropic hormone(ACTH) in human EDTAplasma on Tosoh AIA SystemAnalyzers. | Immunoassay for the in vitroquantitative determination ofadrenocorticotropic hormone(ACTH) in human EDTAplasma. Theelectrochemiluminescenceimmunoassay "ECLIA" isintended for use on the RocheElecsys 1010/2010 andMODULAR ANALYTICSE170 (Elecsys module)immunoassay analyzers. |
| Intended Use Calibrators | ST AIA-PACK ACTHCalibrator Set is intended forIN VITRO DIAGNOSTICUSE ONLY for the calibrationof the ST AIA-PACK ACTHassay on Tosoh AIA SystemsAnalyzers. | Elecsys ACTH CalSet is usedfor calibrating the quantitativeElecsys ACTH assay on theElecsys immunoassayanalyzers. |
| Intended Use Controls | The AIA-PACK ACTHCONTROL SET is intendedfor IN VITRO DIAGNOSTICUSE ONLY for performingquality control procedureswith the ST AIA-PACKACTH Assay. | Elecsys PreciControl ACTH isused for quality control of theElecsys ACTH immunoassayon the Elecsys immunoassayanalyzers. |
| Indications for Use | Plasma ACTH measurementsare useful in the differentialdiagnosis of pituitaryCushing's disease (ACTHhypersecretion),adrenocortical insufficiency(Addisons disease), pituitarytumors (e.g. Nelson'ssyndrome), hypopituitarismwith ACTH deficiency andectopic ACTH syndrome. | ACTH measurements are usedin the differential diagnosisand treatment of certaindisorders of the adrenal glandssuch as Cushings syndrome,adrenocortical insufficiency,and ectopic ACTH syndrome. |
| Assay Protocol | Sandwich assay | Sandwich Assay |
| Sample Type | Human EDTA Plasma | Human EDTA Plasma |
| Assay Low | 2.0 pg/mL | 1.0 pg/mL |
| Assay High | 2000 pg/mL | 2000 pg/mL |
| Reference Range | 7.4-64.3 pg/mL | 7.2-63.3 pg/mL |
| Hook Effect | No high dose hook effect up to1,000,000 pg/mL | No high dose hook effect up to1,000,000 pg/mL |
| Control level | Two levels of control:lyophilized | Two levels of control:lyophilized |
ST AIA-PACK ACTH
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Differences:
| Item | DeviceST AIA-PACK ACTH | PredicateElecsys ACTH |
|---|---|---|
| Detection Protocol | Fluorescence | Electrochemiluminescent |
| Calibrator | ST AIA-PACK Calibrator Set6-Point | ACTH CalSet 2-Point |
| Calibration Interval | 90 days when using same testcup lot | 3-28 Days depending onanalyzer and storageconditions |
| Calibration Verification | 6-Point Calibration does notrequire calibration verificationmaterial | 3 levels ACTH CalCheck |
| Traceability / Standardization | ACTH (Human, 1-39)Bachem AG: code. H-1160;gravimetric preparation | Standardized gravimetricallywith synthetic ACTHproduced by Roche |
| Base Matrix (Control &Calibrator) | MOPSO Buffer with 5%Bovine Serum Albumin | Equine serum |
| Reconstituted stability | Up to 7 days when stored at 2- 8° C when not in use. | Up to 3 hours at 20 - 25° C;- 20° C one month. |
.
ST AIA-PACK ACTH
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Precision:
The precision study was developed with reference to the CLSI protocol entitled: Evaluation of Precision Performance of Quantitative Measurement Methods (EPS-A2).
The precision study for the ST AIA-PACK ACTH assay was evaluated utilizing three AIA-2000 analyzers and 3 different lots of reagents. Precision was assessed by assaying three levels of unaltered EDTA plasma specimens. Estimates of total and within-run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days. This equaled to a total of 40 runs and 80 determinants.
| Specimen | Reagent Set # 1 | Reagent Set # 2 | Reagent Set # 3 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean(pg/mL) | PooledSD | CV% | Mean(pg/mL) | PooledSD | CV% | Mean(pg/mL) | PooledSD | CV% | |
| EDTAPlasma-A | 37.8 | 1.2 | 3.1 | 44.3 | 1.2 | 2.8 | 40.9 | 0.89 | 2.2 |
| EDTAPlasma-B | 223.7 | 4.8 | 2.1 | 244.6 | 5.1 | 2.1 | 230.0 | 5.3 | 2.3 |
| EDTAPlasma-C | 709.2 | 10.9 | 1.5 | 740.4 | 15.6 | 2.1 | 719.1 | 15.5 | 2.2 |
Within Run Precision:
..............................................................................................................................................................................
Total Precision:
| Reagent Set # 1 | Reagent Set # 2 | Reagent Set # 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Specimen | Mean(pg/mL) | PooledSD | CV% | Mean(pg/mL) | PooledSD | CV% | Mean(pg/mL) | PooledSD | CV% |
| EDTAPlasma-A | 37.8 | 1.2 | 3.3 | 44.3 | 1.9 | 4.2 | 40.9 | 1.03 | 2.5 |
| EDTAPlasma-B | 223.7 | 5.7 | 2.5 | 244.6 | 9.3 | 3.8 | 230.0 | 6.4 | 2.8 |
| EDTAPlasma-C | 709.2 | 15.6 | 2.2 | 740.4 | 25.1 | 3.4 | 719.1 | 15.9 | 2.2 |
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Linearity:
The linearity study was developed with reference to the CLSI protocol entitled: Evaluation of the Linearity of Quantitative Measurement Procedures (EP6-A).
The repeatability CV% met the criterion of <= 10%. Therefore, the ST AIA-PACK ACTH has been demonstrated to be linear from 2.0 to 2,000 pg/mL.
Correlation:
The methods comparison study was conducted with reference to the CLSI protocol entitled: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP9-A2).
A total of 160 EDTA plasma specimens (154 unaltered and 6 altered specimens) were assayed in singleton utilizing the ST AIA-PACK ACTH assay on the AIA-2000 analyzer and the Roche Elecsys-ACTH on the MODULAR ANALYTICS E170 (Elecsys module) analyzer. A combination of fresh and frozen specimens was utilized for this study. Six of the 160 specimens were mixed using two or more specimens and altered.
| Deming | Regular | |
|---|---|---|
| Slope: | 1.10 (1.075 to 1.116) | 1.09 (1.067 to 1.107) |
| Intercept: | -0.84 (-8.921 to 7.234) | 0.76 (-7.305 to 8.817) |
| 95% Confidence Intervals are shown in parentheses | ||
| Corr Coef (R): | 0.993 | |
| Bias: (all samples) | 17.8 pg/mL | |
| Points (Plotted/Total): | 160/160 | |
| Result Ranges: | 3.8 to 1986 pg/mL |
The mean bias at the medical decision point (between 7.4 and 64.3 pg/mL) is 4.87 pg/mL. The bias at 7.73 pg/mL is -0.87 pg/mL. The bias at 64.97 pg/mL is -17.93 pg/mL.
Limit of Detection (LoD) and Limit of Quantitation (LoQ):
The LoB and LoD for ST AIA-PACK ACTH was determination was based on guidance from CLSI Protocol EP17-A. While the calculated LoQ is 1.2 pg/mL, the assay low claim is 2.0 pg/mL. This value is a conservative claim in the event of lot-to-lot variability.
The LoB was determined to be 0.5 pg/mL. The LoD was determined to be 0.7 pg/mL. The LoQ was determined to be 1.2 pg/mL
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Interference:
The criterion for recovery was set at 100 +/- 10%. If a specimen recovered within 100 +/- 10%, it was considered as no interference from the particular substance.
-
- Added hemoglobin (up to 440 mg/dL) did not interfere with the assay.
-
- Conjugated bilirubin (up to 19 mg/dL) and free bilirubin (up to 17 mg/dL) did not interfere with the assay.
-
- Lipemia, as indicated by added triglyceride (up to 1,600 mg/dL), did not interfere
-
- Ascorbic acid (up to 20 mg/dL) did not interfere with the assay.
-
- EDTA.2K (up to 7 mg/mL) did not interfere with the assay.
-
- Protein, as indicated by human albumin concentrations (up to 5.0 g/dL), did not interfere with the assay.
-
- Rheumatoid factor did not interfere with ACTH assay up to 500 IU/mL.
-
- Heparin (up to 50 U/mL) does not interfere with the assay.
-
- Acetominaphen (up to 20 mg/L) does not interfere with the assay.
-
- Acetylsalicylic acid (up to 300 mg/L) does not interfere with the assay.
-
- Ampicillin (up to 200 mg/L) does not interfere with the assay.
-
- Ibuprofen (up to 50 mg/L) does not interfere with the assay.
-
- Theophylline (up to 10 mg/L) does not interfere with the assay.
Specificity:
The recovery of ACTH should be within 90 - 110%.
| ACTHFragment | ACTHfragmentconc.[pg/mL] | Measured ACTH conc.[pg/mL] | Average | Difference(measured- original) | ACTHRecovery[%] | % Cross-reactivity | |
|---|---|---|---|---|---|---|---|
| (Control) | 0 | 55.1 | 53.6 | 54.3 | --- | --- | --- |
| ACTH 1-10 | 500 | 54.4 | 54.2 | 54.3 | 0.0 | 100% | -0.01% |
| 5,000 | 55.0 | 54.4 | 54.7 | 0.4 | 101% | 0.01% | |
| 100,000 | 55.3 | 56.1 | 55.7 | 1.3 | 102% | 0.00% | |
| ACTH 11-24 | 500 | 53.5 | 53.4 | 53.4 | -0.9 | 98% | -0.18% |
| 5,000 | 54.1 | 53.0 | 53.6 | -0.8 | 99% | -0.02% | |
| 100,000 | 53.8 | 53.8 | 53.8 | -0.5 | 99% | 0.00% | |
| Beta-MSH | 500 | 53.7 | 54.0 | 53.8 | -0.5 | 99% | -0.10% |
| 5,000 | 54.1 | 54.9 | 54.5 | 0.2 | 100% | 0.00% | |
| 100,000 | 51.1 | 52.1 | 51.6 | -2.8 | 95% | 0.00% | |
| Beta-Endorphin | 500 | 53.1 | 53.0 | 53.0 | -1.3 | 98% | -0.26% |
| 5,000 | 54.9 | 53.5 | 54.2 | -0.1 | 100% | 0.00% | |
| 100,000 | 53.1 | 52.5 | 52.8 | -1.5 | 97% | 0.00% |
ACTH 1-10, 11-24, beta-MSH and beta-Endorphin do not interfere the assay up to 100,000 pg/mL.
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ACTH recovery was less than 90% in the presence of ACTH 1-17, 1-24, 18-39, alpha-MSH (>5,000pg/mL) or ACTH 22-39 (>100,000 pg/mL). These fragments may negatively affect the ACTH assay. It is likely that these fragments bind to either the antibodies on beads or the enzyme-labeled antibodies. Therefore, if these fragments were contained excessively in the test sample, lower values may be reported.
Standards:
| Number | FDARecognitionNumber | RevisionDate | Title |
|---|---|---|---|
| C28-A3 | 7-202 | 09/08/2009 | How to Define and Determine Reference Intervalsin the Clinical Laboratory-Third Edition |
| EP5-A2 | 7-110 | 10/31/2005 | Evaluation of Precision Performance ofQuantitative Measurement Methods: ApprovedGuideline- Second Edition |
| EP6-A | 7-193 | 03/18/2009 | Evaluation of the Linearity of QuantitativeMeasurement Procedures; A Statistical Approach;Approved Guideline |
| EP9-A2 | 7-92 | 03/08/2004 | Method Comparison and Bias Estimation UsingPatient Samples; Approved Guideline-SecondEdition |
| EP17-A | 7-194 | 03/18/2009 | Protocols for Determination of Limits of Detectionand Limits of Quantitation: Approved Guideline |
Control Value Assignment:
The control value assignments are established on 2 analyzers with 2 lots of ST AIA-PACK ACTH. Both levels of control are assayed in 5 replicates, and the Mean and %CV are calculated. This mean serves as the Grand Mean for the Control Assigned Value Range Validation. The range is established as +/- 20% of the grand mean. The validation acceptance criteria is +/- 10% of the grand mean. The end users are instructed to establish their own range.
Conclusion:
The Tosoh Bioscience, Inc. ST AIA-PACK ACTH is substantially equivalent to the Roche Diagnostics Elecsys ACTH Immunoassay (k)060585 for the in vitro diagnostic use only for the quantitative measurement of ACTH in human EDTA plasma, on Tosoh AIA System Analyzer. Since ACTH is controlled by factors affecting the hypothalamic, pituitary and adrenal glands, the determination of ACTH level is useful in clinical investigation for diseases of these glands.
)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers.
10903 New Hampshire Avenue Silver Spring, MD 20993
TOSOH BIOSCIENCE, INC c/o Judith Ogden 6000 Shoreline Court Suite 101 South San Francisco, CA 94080
DEC - 1 2011
Re: K111335
Trade Name: ST AIA-PACK ACTH, ST AIA-PACK ACTH Calibrator Set. AIA-PACK ACTH Control Set Regulation Number: 21 CFR 862.1025 Regulation Name: Adrenocorticotropic hormone (ACTH) test system Regulatory Class: Class II Product Codes: CKG, JIT, JJX Dated: November 15, 2011 Received: November 16, 2011
Dear Ms. Ogden:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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. I You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.html
Sincerely yours,
$\qquad$
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indication For Use:
Device Name:
Indication For Use:
Device Name:
Indication For Use:
ST AIA-PACK ACTH
ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
ST AIA-PACK ACTH Calibrator Set
ST AIA-PACK ACTH Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers
ST AIA-PACK ACTH Control Set
ST AIA-PACK ACTH Control Set is designed for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers
Prescription Use V (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K-111335
§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.
(a)
Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.(b)
Classification. Class II.