(57 days)
Elecsys ACTH Assay: Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers.
Elecsys ACTH CalCheck: For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers.
Elecsys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.
(1) The Elecsys ACTH Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
(2) The Elecsys ACTH CalSet is a lyophilized product consisting of equine serum with added ACTH in two concentration range. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(3) The Elecsys ACTH CalCheck is a lyophilized product consisting of buffered equine serum with added ACTH. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(4) The Elecsys PreciControl ACTH is a lyophilized product consisting of equine serum with added ACTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Note: The reagent, calibrator, calibration verification material and the quality control are all packaged separately.
This document describes the Elecsys ACTH Immunoassay, CalSet, CalCheck, and PreciControl ACTH. The study focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria with acceptance criteria and a study to prove it.
However, based on the provided text, we can extract the reported performance of the device and compare it to the predicate device, which implicitly serves as a benchmark for "acceptance." The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for the Elecsys ACTH system, but rather presents its performance characteristics and compares them to legally marketed predicate devices to establish substantial equivalence.
Here's an attempt to structure the information in the requested format, acknowledging the limitations of the provided text which is a 510(k) summary focused on substantial equivalence rather than a detailed performance study report:
1. Table of Acceptance Criteria and Reported Device Performance
Since no explicit "acceptance criteria" are given for the Elecsys ACTH Immunoassay, the table below presents its reported performance characteristics and compares them to the predicate Immulite ACTH assay, as demonstrating comparable performance to a legally marketed device is the basis for 510(k) clearance. The implied "acceptance criteria" for a 510(k) submission is that the new device performs acceptably and substantially equivalently to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Elecsys ACTH Immunoassay Reported Performance |
|---|---|---|
| Measuring Range | 5 – 1,250 pg/mL | 1 – 2,000 pg/mL |
| Precision (Intra-assay/Within-run) | < 10% CV (e.g., 6.7-9.5% CV for predicate) | Elecsys 1010/2010: < 3% CV (2.0-2.9% CV) E170: < 3% CV (0.6-2.7% CV) |
| Precision (Total/Inter-assay) | < 11% CV (e.g., 6.1-10.0% CV for predicate) | Elecsys 1010/2010: < 6% CV (1.7-5.4% CV) E170: < 6% CV (1.8-5.4% CV) |
| Analytical Sensitivity (LDL) | 5 pg/mL | 1.0 pg/mL |
| Method Comparison (Linear Regression) | Good correlation with predicate (e.g., r=0.988) | y = 0.90x + 8.17, r = 0.992 (vs. commercially available ACTH test) |
| Hook Effect | No high dose hook effect up to 1,500,000 pg/mL | No high dose hook effect up to 1,000,000 pg/mL |
| Analytical Specificity (Cross-reactivity) | Limited cross-reactivity for specific substances | No cross-reactivity for ACTH (1-10), ACTH (11-24), Beta MSH, Beta Endorphin. Interference with some ACTH fragments noted. |
| Interferences (Limitations) | Unaffected by specified common interferents | Unaffected by Icterus, Hemolysis, Lipemia, Biotin (up to certain levels). No interference from rheumatoid factors (up to 400 IU/mL) or 17 common pharmaceuticals. |
Study Proving Device Meets Acceptance Criteria (as per 510(k) Summary):
The document provided is a 510(k) Summary, which aims to demonstrate "substantial equivalence" of the new device (Elecsys ACTH Test System) to legally marketed predicate devices. The "study" referenced within this context is a series of performance evaluations and comparisons described in the "Substantial equivalence" sections. The Elecsys ACTH Immunoassay's performance characteristics (measuring range, precision, sensitivity, method comparison, specificity, and interferences) were measured and compared to the predicate Immulite ACTH assay (K960066) or other relevant predicate devices for the CalSet, CalCheck, and PreciControl components.
The data presented shows that the Elecsys ACTH Immunoassay generally meets or exceeds the performance of the predicate device, particularly in terms of measuring range, precision, and analytical sensitivity. The method comparison also indicates a strong correlation with a commercially available ACTH test.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Method Comparison (Test Set): n=180 samples were used for the method comparison study (Elecsys ACTH (y) vs. a commercially available ACTH test (x)).
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a global company (Roche Diagnostics), it is likely to include data from various testing sites, potentially international, and both prospective and retrospective samples may have been used. However, this information is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts & Qualifications: This is not applicable in the context of an immunoassay performance study. The "ground truth" for the test set (patient samples) would be the actual ACTH concentration as determined by a reference method or a legally marketed comparative device, not by expert interpretation. The commercially available ACTH test (x) used for method comparison serves as the reference for comparative accuracy.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. For quantitative immunoassays, the "ground truth" is typically established by quantitative measurement on a reference or predicate device, not by expert adjudication of subjective results.
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
- This is not applicable. The device described is a fully automated immunoassay system for quantitative determination of ACTH levels. It does not involve human readers interpreting images or data where AI assistance would improve their performance. It's an in-vitro diagnostic (IVD) device, not an AI software diagnostic aid for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The Elecsys ACTH Immunoassay is a standalone automated assay. Its performance characteristics (precision, analytical sensitivity, measuring range, specificity) are evaluated as the algorithm/system only, without human intervention in the result generation. Human involvement is limited to sample loading, system maintenance, and result review.
7. The Type of Ground Truth Used
- The "ground truth" for evaluating the Elecsys ACTH Immunoassay's performance (specifically for method comparison) was established by comparison to a commercially available ACTH test. This implies using an already established and validated quantitative method. For other performance aspects like precision and analytical sensitivity, the ground truth is inherent in the known concentrations of spiked samples or statistically derived from repeated measurements.
8. The Sample Size for the Training Set
- The document does not specify a separate "training set" for the assay. For immunoassays, the "training" typically refers to the development and optimization process, where various formulations and parameters are tested. The "calibration" of the device uses reference materials (CalSet) with known concentrations to establish a standard curve. The document mentions a master curve provided with the reagent bar code, which is essentially pre-determined calibration data based on extensive prior testing during development and manufacturing.
9. How the Ground Truth for the Training Set Was Established
- As a traditional immunoassay, there isn't a "training set" in the sense of machine learning algorithms.
- Calibration: The "ground truth" for calibrators (Elecsys ACTH CalSet) is established by spiking known concentrations of ACTH into the matrix and gravimetric standardization with synthetic ACTH produced at Roche.
- Control Materials: Similarly, for control materials (Elecsys PreciControl ACTH), known concentrations of ACTH are spiked into the matrix.
- The "master curve" used by the instrument is derived from extensive testing of reference materials with confirmed ACTH concentrations during the assay development process.
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MAY 3 2006
Confidential
| 510(k) Summary | K 06058 |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| Submittername, address,contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250(317)-521-3532Contact person: Randy J. JohnsonDate Prepared: March 6, 2006 |
| Device Name | Proprietary name: (1) Elecsys ACTH Immunoassay(2) Elecsys ACTH CalSet(3) Elecsys ACTH CalCheck(4) Elecsys PreciControl ACTHCommon name: (1) ACTH Assay(2) ACTH CalSet(3) ACTH CalCheck(4) PreciControl ACTHClassification name: (1) System, Test, ACTH(2) Calibrator, Secondary(3 & 4) Single (specified) analyte controls (assayed andunassayed) |
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| DeviceDescription | (1) The Elecsys ACTH Assay is a two step sandwich immunoassay withstreptavidin microparticles and electrochemiluminescence detection. Resultsare determined using a calibration curve that is generated specifically on eachinstrument by a 2 point calibration and a master curve provided with thereagent bar code.(2) The Elecsys ACTH CalSet is a lyophilized product consisting of equineserum with added ACTH in two concentration range. During manufacture,the analyte is spiked into the matrix at the desired concentration levels.(3) The Elecsys ACTH CalCheck is a lyophilized product consisting ofbuffered equine serum with added ACTH. During manufacture, the analyte isspiked into the matrix at the desired concentration levels.(4) The Elecsys PreciControl ACTH is a lyophilized product consisting ofequine serum with added ACTH in two concentration ranges. Duringmanufacture, the analyte is spiked into the matrix at the desired concentrationlevels.Note: The reagent, calibrator, calibration verification material and the qualitycontrol are all packaged separately. |
|---|---|
| Intended use | (1) Elecsys ACTH Reagent: Immunoassay for the in vitro quantitativedetermination of adrenocorticotropic hormone (ACTH) in human EDTAplasma. The electrochemiluminescence immunoassay "ECLIA" is intendedfor use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.(2) Elecsys ACTH CalSet is used for calibrating the quantitative ElecsysACTH assay on the Elecsys immunoassay analyzers.(3) Elecsys ACTH CalCheck: For use in the verification of the calibrationestablished by the Elecsys ACTH reagent on Elecsys 1010/2010 andMODULAR E170 immunoassay analyzers.(4) Elesys PreciControl ACTH is used for quality control of the ElecsysACTH immunoassay on the Elecsys immunoassay analyzers. |
Continued on next page
:
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and the same of the same of the same of the same of the same of the same of
510(k) Summary, Continued
| Indications for Use | (1) Elecsys ACTH Reagent: Immunoasssay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurments are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome. |
|---|---|
| (2) Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers. | |
| (3) Elecsys ACTH CalCheck: For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers. | |
| (4) Elesys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers. | |
| Substantial equivalence | The Elecsys ACTH Test System is substantially equivalent to other devices legally marketed in the United States. |
| (1) Elecsys ACTH Immunoassay is equivalent to the Immulite ACTH assay (K960066). Both products are intended for use in the quantitative determination of ACTH in plasma. | |
| (2) Elecsys ACTH CalSet is equivalent to the Immulite ACTH assay (K960066). | |
| (3) Elecsys ACTH CalCheck is equivalent to the Elecsys Prolactin II CalCheck (K053059). | |
| (4) Elecsys PreciControl ACTH is equivalent to the Elecsys PreciControl Troponin T (K031990). | |
| Continued on next page |
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510(k) Summary, Continued
| Substantial equivalence - similarities | |
|---|---|
| Substantial equivalence – similarities | ||
|---|---|---|
| Immunoassay Comparison | ||
| Feature | Elecsys ACTH | Predicate DeviceImmulite ACTH Assay |
| Intended Use | Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. | For in vitro diagnostic use with the Immulite 2000 analyzer - for the quantitative measurement of adrenocorticotropic hormone in EDTA, plasma, as an aid in the assessment of adrenal insufficiency and hypersecretion |
| Indication for Use | ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome. | As an aid in the assessment of adrenal insufficiency and hypersecretion. |
| Assay Protocol | Sandwich assay | Solid-phase, two site |
| Detection Protocol | Electrochemiluminescent Immunoassay | Chemiluminescent immunometric assay |
| Sample Type | Human plasma treated with K3-EDTA | Human plasma treated with EDTA |
| Calibrator | ACTH CalSet | ACTH Adjustors (LACL, LACH) |
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:
| CalSet Comparison | ||
|---|---|---|
| Characteristic | Elecsys ACTH CalSet | Predicate DeviceImmulite ACTH Assay |
| Intended Use | Used for calibrating the quantitativeElecsys ACTH assay on the Elecsysimmunoassay analyzers. | N/A |
| Levels | Two | Same |
| Format | Lyophilized | Same |
| CalCheck Comparison | ||
| Characteristic | Elecsys ACTH CalCheck | Predicate DeviceElecsys Prolactin II CalCheck |
| Levels | Three | Same |
| Format | Lyophilized | Same |
| Stability | Unopened:Store at 2-8°C up to the printedexpiration date on the bottle labelsReconstituted:15 - 25°C : 4 hrs | Same |
| PreciControl Comparison | ||
| Characteristic | Elecsys ACTH PreciControl | Predicate DeviceElecsys PreciControl Troponin T |
| Levels | Two | Same |
| Format | Lyophilized | Same |
| Handling | Dissolve carefully the contents of onebottle by adding exactly 2.0 mL ofdistilled water and allow to standclosed for 15 minutes to reconstitute.Mix carefully, avoiding the formationof foam. | Same |
Substantial equivalence – similarities, continued
{5}------------------------------------------------
510(k) Summary, Continued
Substantial equivalence - differences
| Substantial equivalence – differences | |||
|---|---|---|---|
| Immunoassay Comparison | |||
| Feature | Elecsys ACTH | Predicate DeviceImmulite ACTH Assay | |
| Traceability /Standardization | Standardized gravimetrically withsynthetic ACTH produced at Roche. | N/A | |
| CalibrationInterval | E170/Elecsys 2010:After 1 month (28 days) when usingthe same reagent lot.After 7 days (when using the samereagent kit on the analyzer).Elecsys 1010:With every reagent kit.After 7 days (20-25°C).After 3 days (25-32°C). | Every four weeks. | |
| Platform | Roche Elecsys 1010/2010 andMODULAR ANALYTICS E170(Elecsys module) analyzers. | Immulite 2000 Analyzer | |
| CalibrationVerification | ACTH CalCheck | None stated in the package insert. | |
| Controls | PreciControl ACTH | LACCM: Bi-level ACTH controlmodule (protein based).. | |
| Reagent Stability | Unopened:2-8°C - Up to the stated expirationdateOpened:2-8°C - 12 weeksOn the E170 / Elecsys 2010 – 4weeksOn the Elecsys 1010: – 4 weeks(stored alternately in the refrigeratorand on the analyzer- ambienttemperature 20-25°C; up to 20 hoursopened in total.) | ACTH Reagent Wedge:Stable at 2 – 8°C until the expirationdate. | |
| MeasuringRange | 1 – 2,000 pg/mL | 5 – 1,250 pg/mL | |
| Feature | Elecsys ACTH | Predicate DeviceImmulite ACTH Assay | |
| Precision | Elecsys 1010/2010:Within-run2.9% CV @ 4.9 pg/mL2.0% CV @ 74.2 pg/mL2.1% CV @ 1,390 pg/mL1.5% CV @ 115 pg/mL1.6% CV @ 970 pg/mLTotal5.4% CV @ 4.9 pg/mL2.4% CV @ 74.2 pg/mL2.6% CV @ 1,390 pg/mL1.7% CV @ 115 pg/mL1.8% CV @ 970 pg/mLE170:Within-run2.7% CV @ 4.9 pg/mL0.6% CV @ 64.3 pg/mL0.7% CV @ 1,205 pg/mL0.6% CV @ 111 pg/mL1.2% CV @ 968 pg/mLTotal5.4% CV @ 4.96 pg/mL3.5% CV @ 76.1 pg/mL3.7% CV @ 1,444 pg/mL1.8% CV @ 114 pg/mL2.0% CV @ 972 pg/mL | Intra-assay:8.7% CV @ 23 pg/mL6.7% CV @ 30 pg/mL6.8% CV @ 40 pg/mL6.9% CV @ 208 pg/mL9.5% CV @ 421 pg/mLInterassay:10.0% CV @ 24 pg/mL8.2% CV @ 44 pg/mL8.7% CV @ 89 pg/mL9.3% CV @ 229 pg/mL6.1% CV @ 496 pg/mL | |
| Analyticalsensitivity (LDL) | 1.0 pg/mL | 5 pg/mL | |
| Immunoassay Comparison | |||
| Feature | Elecsys ACTH | Predicate DeviceImmulite ACTH Assay | |
| MethodComparison(LinearRegression) | Elecsys ACTH (y) versus acommercially available ACTH test (x):$y= 0.90x + 8.17, r = 0.992, n=180$ | DPC Immulite 2000 versus DPC Immulite:$(IML 2000) = 0.95 (IML) + 2.9 pg/mL$$r=0.988, n = 86$ | |
| AnalyticalSpecificity | No cross reactivity for:ACTH (1-10)ACTH (11-24)Beta MSHBeta EndorphinACTH fragments:(ACTH 1-17, ACTH 1-24, ACTHCLIP 18-39, ACTH 22-39, AlphaMSH 1-13) > 5,000 pg/mL can bindto one of the antibodies and therebynegatively interfere with thesandwich formation and lead tolower ACTH values.Under ACTH (1-24) medication,ACTH measurement is notrecommended. POMC (partiallypurified from an adenoma cell line)showed an approximate 1.6% cross-reactivity at 1,560 pmol/L which isapproximately forty times thephysiological concentration ofACTH precursors in circulation. | No cross reactivity for:ACTH (1-18)Cross reactivity:ACTH (1-24)ACTH (18-39)Alpha MSH | |
| Hook Effect | No high dose hook effect up to1,000,000 pg/mL | No high dose hook effect up to1,500,000 pg/mL | |
| Substantial equivalence – differences | |||
| Immunoassay Comparison | |||
| Feature | Elecsys ACTH | Predicate DeviceImmulite ACTH Assay | |
| Limitations | The assay is unaffected by:Icterus (bilirubin <428 µmol/L or <25 mg/dL Hemolysis (<0.25 mmol/L or <0.4 g/dL) Lipemia (Intralipid < 1,500 mg/dL) Biotin (<246 nmol/L or, 60 ng/mL) In patients receiving therapy with high biotin doses (i.e > 5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration No interference was observed from rheumatoid factors up to a concentration of 400 IU/mL In vitro tests were performed on 17 commonly used pharmaceuticals. No interference was found with the assay Under ACTH 1-24 medication, ACTH measurement is not recommended, due to negative interference with the sandwich assay | The assay is unaffected by:Bilirubin: (Up to 200 mg/L) Hemolysis: (Up to 512 mg/dL) Lipemia: (Triglycerides up to 5,000 mg/dL) Heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays. Samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result. These reagents have been formulated to minimize the risk of interference, however, potential interactions between rare sera and test components can occur. |
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Substantial equivalence - differences
{7}------------------------------------------------
Substantial equivalence - differences
{8}------------------------------------------------
Substantial equivalence - differences
{9}------------------------------------------------
| Feature | Elecsys ACTH | Predicate DeviceImmulite ACTH Assay |
|---|---|---|
| Limitations | Erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal antibodies or have received them for diagnostic purposes. In rare cases, interference due to extremely high titers of antibodies to ruthenium can occur. Elecsys ACTH contains additives which minimize these effects. Extremely high titers of antibodies to streptavidin can occur in isolated cases and cause interference. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings | For diagnostics purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings. |
Substantial equivalence - differences
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| CalSet Comparison | ||
|---|---|---|
| Substantial equivalence - differences | ||
| Characteristic | Elecsy ACTH CalSet | Predicate deviceImmulite ACTH Assay |
| Matrix | Equine serum | Bovine protein-based |
| Stability | Unopened:• Store at 2-8°C until expirationdate.Reconstituted or thawed:• 2-8°C: 1 week• -20°C: 3 months (freeze onlyonce)• on Elecsys 1010/2010 at 20-25°C: Up to 5 hours• on E170: Use only once | Reconstituted:• -20°C: 2 months |
| Handling | Dissolve carefully the contents ofone bottle by adding exactly 1.0mL of distilled water and allow tostand closed for 15 minutes toreconstitute. Mix carefully,avoiding the formation of foam. | Reconstitute each vial with 4.0 mLdistilled or deionized water. Let standfor 30 minutes, then mix by gentleswirling or inversion. |
Substantial equivalence -- differences
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| CalCheck Comparison | ||
|---|---|---|
| Characteristic | Elecsys ACTH CalCheck | Predicate deviceElecsys Prolactin II CalCheck |
| Intended Use | For use in the verification of thecalibration established by theElecsys ACTH reagent on Elecsys1010/2010 and MODULAR E170immunoassay analyzers. | For use in the verification of thecalibration established by the ElecsysProlactin II reagent on Elecsys1010/2010 and MODULARANALYTICS E170 immunoassayanalyzers. |
| Matrix | Buffered equine serum withsynthetic 1-39 ACTH. | Buffered equine serum withrecombinant human Prolactin from E.Coli |
| Handling | Reconstitute the contents withexactly 2.0 mL distilled water ordeionized water. Allow the bottleto stand closed for 15 minutes. Mixby inversion to ensurehomogeneity. | Reconstitute the contents with exactly1.0 mL distilled or deionized water.Allow the bottle to stand closed for 15minutes. Mix by inversion to ensurehomogeneity. |
| Traceability | Standardized gravimetrically withsynthetic ACTH produced atRoche. | Standardized against the 3rd IRP WHOReference Standard 84/500. |
Substantial equivalence - differences
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| Characteristic | CalCheck ComparisonElecsys ACTH CalCheck | Predicate deviceElecsys Prolactin II CalCheck | |
|---|---|---|---|
| Intended Use | For use in the verification of thecalibration established by theElecsys ACTH reagent on Elecsys1010/2010 and MODULAR E170immunoassay analyzers. | For use in the verification of thecalibration established by the ElecsysProlactin II reagent on Elecsys1010/2010 and MODULARANALYTICS E170 immunoassayanalyzers. | |
| Matrix | Buffered equine serum withsynthetic 1-39 ACTH. | Buffered equine serum withrecombinant human Prolactin from E.Coli | |
| Handling | Reconstitute the contents withexactly 2.0 mL distilled water ordeionized water. Allow the bottleto stand closed for 15 minutes. Mixby inversion to ensurehomogeneity. | Reconstitute the contents with exactly1.0 mL distilled or deionized water.Allow the bottle to stand closed for 15minutes. Mix by inversion to ensurehomogeneity. | |
| Traceability | Standardized gravimetrically withsynthetic ACTH produced atRoche. | Standardized against the 3rd IRP WHOReference Standard 84/500. |
Substantial equivalence - differences
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Status and States of Children and Children and Children Children Children and Children Children Children Children Children Children Children Children Children Children Childr
510(k) Summary, Continued
| PreciControl Comparison | ||
|---|---|---|
| Characteristic | Elecsy PreciControl ACTH | Predicate DeviceElecsys PreciControl Troponin T |
| Intended Use | Used for quality control of theElecsys ACTH immunoassay onthe Elecsys immunoassayanalyzers. | Used for quality control of the ElecsysTroponin T (Cardiac T) immunoassayon the Elecsys immunoassay systems. |
| Matrix | Equine serum with added syntheticACTH | Troponin T (recombinant, human) inhuman serum |
| Stability | Unopened:Store at 2-8°C up to the statedexpiration date | Unopened:Store at 2-8°C up to the statedexpiration date |
| Reconstituted:On the analyzer at 20 - 25°C: Up tothree hours. | Reconstituted:On the analyzer at 20 - 25°C: Up tofive hours. | |
| -20 °C : One month (freeze onlyonce) | -20 °C : Three months (freeze onlyonce) | |
| After thawing: Use only once. | After thawing: Use only once. | |
Substantial equivalence – differences
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/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 bars representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 3 2006
Randy Johnson MT (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416
K060585 Re:
Trade/Device Name: Elecsys ACTH Test System Regulation Number: 21 CFR§862.1025 Regulation Name: Adrenocorticotropic hormone (ACTH) test system Regulatory Class: Class II Product Code: CKG, JIT, JJX Dated: March 6, 2006 Received: March 7, 2006
Dear Mr. Johnson:
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. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto
Alberto Gutierrez, Ph.D.
Director Division of Chemistry and Toxicology 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): K060585
Elecsys ACTH Test System Device Name:
Indications For Use:
Elecsys ACTH Assay:
Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers.
Elecsys ACTH CalCheck:
For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers.
Elecsys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
310(k) kAlosys
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§ 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.