(18 days)
The AquaLite® Free T Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Free T . Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human free T4 in serum.
The AquaLite® FT4 Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® F14 Assay) is an in vitro diagnostic product intended for use in the quantitative measurement of FT4 in human serum in clinical laboratories. Free thyroxine measurements are used to diagnosis and treat diseases of the thyroid.
The AquaLite® Free T. Assay is a single-site, competitive inhibition bioluminescent immunoassay kit. A T carrier complex is immobilized on polystyrene tubes (solid phase). Serum samples, appropriate calibrators or controls, are pipetted (50 uL) into the pre-coated tubes. A mouse monoclonal anti-T antibody covalently linked to AquaLite® (100 uL) is then added to the tubes. Free T. in the sample competes with immobilized T for the available T binding sites of the anti-T antibody conjugate. Complex formation is complete after a 90-minute incubation period at room temperature on a standard orbital shaker. The tubes are then washed to remove unbound conjugate.
The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The presence of Ta in the sample or calibrator reduces the binding of the conjugate to the immobilized T . pre-coated on the tubes. The amount of signal inhibition is indirectly proportional to the Free T concentration. To calculate results, the luminometer uses a cubic spline curve fit applied to a log-log transformation of the light intensity (in relative light units, RLU) of the Free T calibrators versus Free T, concentration (in ng/dL).
The document describes a 510(k) submission for the SeaLite Sciences, Inc. AquaLite® Free T Assay, a bioluminescent immunoassay kit for the quantitative determination of human free T4 in serum. The submission aims to demonstrate substantial equivalence to the Nichols Institute Free T4 Assay.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as pass/fail thresholds in the provided document for all tests, but rather implied by the reported performance and comparison to a legally marketed predicate device. The performance characteristics were generally deemed acceptable by the FDA through the 510(k) clearance process.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 1. Sensitivity/Detection Limit | 0.007 ng/dL (calculated at 95% confidence level of twenty replicates of A Calibrator (0 ng/dL)). |
| 2. Specificity and Cross Reactivity (undetectable interference) | Triiodo-L-thyronine (20 µg/dL): undetectable cross-reactivity.Triiodothyroacetic acid (20 µg/dL): undetectable cross-reactivity.Monoiodotyrosine (20 µg/dL): undetectable cross-reactivity.Diiodo-L-tyrosine (20 µg/dL): undetectable cross-reactivity.Methimazole (0.4 mg/mL): undetectable cross-reactivity.6-n-Propyl-2-thiouracil (0.4 mg/mL): undetectable cross-reactivity. |
| 3. Drift (no significant "end of run" effect) | Two patient samples showed consistent Free T4 levels across 20-30, 50-60, and 90-100 tubes, indicating no significant drift over 100 tubes. (Example: Sample 1: 2.8, 2.9, 2.8 ng/dL; Sample 2: 4.5, 4.5, 4.5 ng/dL). |
| 4. Precision and Reproducibility | Intra-Assay Precision (n=20 per level): - 0.75 ng/dL: 10.1% CV- 2.6 ng/dL: 4.1% CV- 4.4 ng/dL: 2.9% CV Inter-Assay Precision (n=2x20=40 over 2 weeks): - 0.6 ng/dL: 13.0% CV- 2.6 ng/dL: 5.0% CV- 4.2 ng/dL: 3.4% CV |
| 5. Method Comparison (good correlation with predicate) | Linear regression analysis with a commercially available chemiluminescence immunometric assay for Free T4 yielded: - Slope: 1.1- y-intercept: -0.2- Correlation coefficient (r): 0.92 (for Free T4 ranging from 0.27 to 3.67 ng/dL in n=127 serum samples). |
| 6. Kinetics (optimal incubation time) | 90-minute incubation shown to be optimal based on parallel assays of three human serum samples at 60, 90, and 120 minutes. |
| 7. Recovery in Serum and Plasma (no significant differences) | No significant differences found for Free T4 recovery between standard serum, SST tubes, heparin plasma, and EDTA plasma in blood samples from 7 normal subjects. |
| 8. Effect of Hemolysis (not significantly affected) | Not significantly affected by mild, moderate, or severe hemolysis (tested with three patient samples spiked with hemoglobin preparations). |
| 9. Effect of TBG (no interference at normal levels) | No interference at normal TBG levels (15-34 mg/L). Slight inhibition of %B/Bo observed at 200 and 300 mg/L TBG (5.9 and 8.8 times normal physiologic level), potentially leading to an apparent increase in Free T concentration at very high supra-physiological levels. |
| 10. Effect of Albumin (not significantly affected) | Not significantly affected by albumin at concentrations of 15, 25, and 75 mg/mL (tested with three patient samples). |
| 11. Effect of Nonesterified Fatty Acids (not significantly affected) | Not significantly affected by oleic acid at 2.5, 5, and 10 mmol/L (tested with three patient samples). |
| 12. Effect of Bilirubin (not significantly affected) | Not significantly affected by bilirubin at 10 and 20 mg/dL (tested with three patient samples). |
| 13. Effect of Salicylate (not significantly affected) | Not significantly affected by salicylate at 1, 5, 10, and 25 mg/dL (tested with three patient samples). |
| 14. Effect of Phenytoin (potential effect at high levels) | "Not significantly affected by phenytoin at the levels tested" is stated, but the data shows increasing Free T4 values with increasing phenytoin concentrations, particularly at 10 µg/mL and 25 µg/mL (e.g., Sample 1: 1.1 (Neat) to 2.22 (25µg/mL); Sample 2: 1.5 (Neat) to 2.2 ng/mL (25µg/mL)). The accompanying text "Assay is needing to patients falling Should be interpreted with courtion" (sic: caution) suggests a recognition of potential interference at higher levels. This implies that while low levels might not significantly affect, higher levels might, requiring clinical judgment. |
| 15. Effect of Phenylbutazone (not significantly affected) | Not significantly affected by phenylbutazone at 1, 5, and 10 µg/mL (tested with three patient samples). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document doesn't explicitly refer to "test sets" in the modern AI/machine learning sense, but rather "studies" for performance characterization.
- Sensitivity: 20 replicates of a 0 ng/dL calibrator.
- Drift: Two patient samples, each run in 5 duplicates, across 100 tubes (implied data from 10 groups of 10 tubes).
- Intra-assay precision: 20 replicates per concentration level for three serum controls (total 60 measurements).
- Inter-assay precision: Duplicates in 20 assays for three serum controls (total 40 measurements * 3 levels = 120 control measurements, plus each assay included a standard curve).
- Method Comparison: 127 serum samples.
- Kinetics: Three human serum samples.
- Recovery in Serum and Plasma: Blood samples from 7 normal subjects.
- Effect of Hemolysis: Three patient samples.
- Effect of TBG: TBG added to calibrator A (0 ng/dL Free T4) at various concentrations.
- Effect of Albumin: Three patient samples.
- Effect of Nonesterified Fatty Acids: Three patient samples.
- Effect of Bilirubin: Three patient samples.
- Effect of Salicylate: Three patient samples.
- Effect of Phenytoin: Two patient samples.
- Effect of Phenylbutazone: Three patient samples.
Data Provenance: The studies were conducted at SeaLite Sciences, Inc. The samples used (serum controls, patient samples, normal subjects' blood) are implied to be retrospective clinical samples or laboratory-prepared samples. The country of origin is not explicitly stated, but since SeaLite Sciences, Inc. is based in Norcross, GA, and the submission is to the US FDA, it is highly likely the data originated from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For an in vitro diagnostic immunoassay, "ground truth" often refers to reference methods, certified standards, or clinical diagnoses. The document compares the device's performance to established analytical methods and other commercially available assays, implying that these existing methods or values serve as the reference. There's no mention of expert consensus for establishing ground truth for the performance studies themselves, as is common for subjective image interpretation.
4. Adjudication Method for the Test Set
This is not applicable and therefore not described. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., by radiologists) where discrepancies need to be resolved. For an objective quantitative immunoassay, the result is a numerical value, and "adjudication" in this sense is not performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. Such studies are relevant for devices where human interpretation is involved and improved by AI assistance (e.g., AI for radiology). This device is an in-vitro diagnostic immunoassay kit, where the result is quantitative and read by a luminometer, not interpreted by a human reader in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, this entire submission describes the standalone performance of the AquaLite® Free T Assay. As an in-vitro diagnostic assay, it is inherently a "standalone" device providing a quantitative measurement. Human involvement is in sample preparation, running the assay, and interpreting the numerical result in a clinical context, but the assay's performance characteristics (sensitivity, precision, accuracy, etc.) are evaluated intrinsically.
7. The Type of Ground Truth Used
The ground truth or reference used for assessing performance varied by study:
- Sensitivity: Defined using replicates of a 0 ng/dL calibrator.
- Specificity/Cross-reactivity: Measured against known concentrations of potentially interfering compounds.
- Drift, Precision, Kinetics, Interference Studies: Measured against the device's own internal calibration/control system, with consistency and expected behavior serving as the "ground truth."
- Method Comparison: A commercially available chemiluminescence immunometric assay kit for Free T4 was used as the comparator, which serves as a widely accepted reference method in the field for demonstrating substantial equivalence.
- Recovery in Serum and Plasma: Compared to standard serum samples.
Essentially, the ground truth relies on established laboratory practices, verified calibrators, and comparison to a legally marketed predicate device (the Nichols Institute Free T4 Assay) which itself would have been validated against accepted reference methods.
8. The Sample Size for the Training Set
This information is not provided and is not typically described in a 510(k) submission for an immunoassay. Immunoassay development relies on chemical and biological optimization, rather than a "training set" in the machine learning sense. The "standard curve" generated for each assay run is analogous to a form of internal calibration or "on-the-fly training," but this differs from a large, predefined training dataset for an algorithm.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the machine learning context for this device, this question is not applicable. The underlying principles of the immunoassay (antibody-antigen binding, bioluminescence) are based on established scientific knowledge. The "ground truth" for the calibrators used in each assay's standard curve would have been established through a robust process of analytical validation, likely involving established reference materials and methods, but the details are not in this document.
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DEC 2 2 1997
SeaLite Sciences, Inc.
510(k) SUMMARY
I. GENERAL INFORMATION
Trade or proprietary name - SeaLite Sciences, Inc. AquaLite® Free T, Assay
Common or usual name - Bioluminescent immunoassay (BIA)
Classification name - FDA has classified Free To test systems intended for the measurement of free thyroxine in serum or plasma to diagnose and treat diseases of the thyroid as Class II devices. (21 C.F.R. § 862.1695)
| Submitter's Name | Cathryn N. Cambria, Director |
|---|---|
| and Address: | Regulatory Affairs and Quality Assurance |
| SeaLite Sciences, Inc. | |
| 3000 Northwoods Parkway | |
| Suite 200 | |
| Norcross, GA 30071 | |
| (800) 874-4471, ext. 227 | |
| Submission Date: | December 3, 1997 |
Legally Marketed Device To Which Claim Substantial Equivalence:
Nichols Institute Free T4 Assay
II. INDICATIONS FOR USE
The AquaLite® Free T Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Free T . Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human free T4 in serum.
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III. DEVICE DESCRIPTION
The AquaLite® Free T. Assay is a single-site, competitive inhibition bioluminescent immunoassay kit. A T carrier complex is immobilized on polystyrene tubes (solid phase). Serum samples, appropriate calibrators or controls, are pipetted (50 uL) into the pre-coated tubes. A mouse monoclonal anti-T antibody covalently linked to AquaLite® (100 uL) is then added to the tubes. Free T. in the sample competes with immobilized T for the available T binding sites of the anti-T antibody conjugate. Complex formation is complete after a 90-minute incubation period at room temperature on a standard orbital shaker. The tubes are then washed to remove unbound conjugate.
The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The presence of Ta in the sample or calibrator reduces the binding of the conjugate to the immobilized T . pre-coated on the tubes. The amount of signal inhibition is indirectly proportional to the Free T concentration. To calculate results, the luminometer uses a cubic spline curve fit applied to a log-log transformation of the light intensity (in relative light units, RLU) of the Free T calibrators versus Free T, concentration (in ng/dL).
SUMMARY OF STUDIES AND TECHNOLOGICAL CHARACTERISTICS IV.
Studies on the AquaLite® Free T. Assay were conducted at SeaLite Sciences. The results are summarized below:
Performance Characteristics
1. Sensitivity
The sensitivity or detection limit of the AquaLite® Free T. Assay is 0.007 ng/dL. Sensitivity is calculated by determining the Free Ta concentration that corresponds to the 95% confidence level of twenty replicates of the A Calibrator (0 ng/dL).
2. Specificity and Cross Reactivity
Cross reactivity of the AquaLite® Free T Assay was determined by spiking Calibrator A containing Free Ta (0 ng/dL) with the following compounds.
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| Compound | Concentration | % Cross Reactivity |
|---|---|---|
| Triiodo-L-thyronine | 20 µg/dL | undetectable |
| Triiodothyroacetic acid | 20 µg/dL | undetectable |
| Monoiodotyrosine | 20 µg/dL | undetectable |
| Diiodo-L-tyrosine | 20 µg/dL | undetectable |
| Methimazole | 0.4 mg/mL | undetectable |
| 6-n-Propyl-2-thiouracil | 0.4 mg/mL | undetectable |
3. Drift
Two patient samples were run (5 duplicates each) and assayed for reagent addition drift. The data demonstrate that the AquaLite® Free T. Assay does not exhibit "end of run" effect with 100 tubes.
| (All measurements, in ng/dL) | |||
|---|---|---|---|
| Tubes | Tubes | Tubes | |
| Sample | 20-30 | 50-60 | 90-100 |
| 1 | 2.8 | 2.9 | 2.8 |
| 2 | 4.5 | 4.5 | 4.5 |
Precision and Reproducibility 4.
- Intra-assay precision. Three serum controls containing Free T4 at the a. following concentrations were assayed to determine intra-assay precision (n=20 per concentration level).
| Free T4 Level (ng/dL) | % CV |
|---|---|
| 0.75 | 10.1 |
| 2.6 | 4.1 |
| 4.4 | 2.9 |
- Inter-assay precision. Three serum controls containing Free T4 at the b. following concentrations were assayed in duplicate in 20 assays. A new standard curve was generated for each assay (n = 2 x 20 = 40). Inter-assay precision observed over a 2 week period for the solutions is as follows:
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| Free T4 Level (ng/dL) | % CV |
|---|---|
| 0.6 | 13.0 |
| 2.6 | 5.0 |
| 4.2 | 3.4 |
5. Method Comparison
Free Tg ranging from 0.27 to 3.67 ng/dL in serum samples (n = 127) was measured using the AquaLite® Free T Assay and a commercially available chemiluminescence immunometric assay kit for Free T4. Correlation by linear regression analysis gave a slope of 1.1 with a y intercept of -0.2. The correlation coefficient was 0.92.
6. Kinetics
Three human serum samples were assayed in parallel at 60 minutes, 90 minutes and 120 minutes to demonstrate the effect of incubation times. Results indicate a 90 minute incubation is optimal.
| Standardng/dL | 1 Hour%B/Bo | 1.5 Hours%B/Bo | 2 Hours%B/Bo |
|---|---|---|---|
| 0 | 100.0 | 100.0 | 100.0 |
| 0.4 | 85.9 | 84.0 | 82.6 |
| 0.9 | 68.8 | 68.1 | 68.8 |
| 2 | 38.0 | 38.4 | 41.2 |
| 4 | 8.6 | 9.1 | 10.7 |
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| Sampleng/dL | Free T4ng/dL | Free T4ng/dL | Free T4ng/dL |
|---|---|---|---|
| 1 | 0.6 | 0.6 | 0.5 |
| 2 | 2.6 | 2.6 | 2.7 |
| 3 | 4.4 | 4.4 | 4.4 |
7. Recovery in Serum and Plasma
Blood samples from 7 normal subjects were prepared as sera (standard technique and SST tubes) as well as heparin and EDTA plasmas. Free T, was quantified using the AquaLite® Free T , Assay . Recovered Free T , was compared with the Free T , recovered in serum (standard technique). The data demonstrates that there are no significant differences between standard serum or serum separator tubes, nor heparin and EDTA plasmas when using the AquaLite® Free T4 Assay.
| Sample | Serum | Heparin | EDTA | SST |
|---|---|---|---|---|
| 1 | 1.5 | 1.4 | 1.4 | 1.3 |
| 2 | 1.5 | 1.6 | 1.5 | 1.4 |
| 3 | 1.6 | 1.8 | 1.5 | 1.4 |
| 4 | 1.8 | 1.7 | 1.8 | 1.6 |
| 5 | 1.4 | 1.4 | 1.4 | 1.3 |
| 6 | 1.3 | 1.3 | 1.5 | 1.2 |
| 7 | 0.9 | 1.0 | 0.8 | 0.6 |
8. Effect of Hemolysis
Three patient samples were spiked with preparations of hemoglobin and assayed to demonstrate effect of mild, moderate and severely hemolyzed serum. The data demonstrates that the AquaLite® Free T. Assay is not significantly affected by hemoglobin.
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| Sample | Neat | Mild | Moderate | Severe |
|---|---|---|---|---|
| 1 | 1.6 | 1.5 | 1.5 | 1.5 |
| 2 | 1.7 | 1.5 | 1.8 | 1.7 |
| 3 | 1.0 | 1.1 | 0.9 | 1.1 |
9. Effect of TBG
This experiment tested for the possible interference of the immobilized Free T with purified TBG. If TBG bound to the immobilized Free T., there would be a reduction of binding of the anti-T. AquaLite® Free T. conjugate. This would be reflected in an apparent increase in Free T concentration. At a normal TBG level (15-34 mg/L)18 there was no interference of the AquaLite® Free T4 Assay. There was slight inhibition of the %B/Bo at 200 and 300 mg/L of TBG (5.9 and 8.8 times normal physiologic level).
| TBG Added | %B/Bo |
|---|---|
| 0 | 100% |
| 50 mg/L | 100 % |
| 75 mg/L | 100% |
| 100 mg/L | 104% |
| 200 mg/L | 91% |
| 300 mg/L | 93% |
| 600 mg/L | 73% |
10. Effect of Albumin
Three patient samples were spiked with 15, 25 and 75 mg/mL of albumin and assayed. The data demonstrate that the AquaLite® Free T4 Assay is not significantly affected by albumin.
| Sample | Neat | Albumin | ||
|---|---|---|---|---|
| 15 mg/mL | 25 mg/mL | 75 mg/mL | ||
| 1 | 1.8 | 1.6 | 1.5 | 1.9 |
| 2 | 1.2 | 1.3 | 1.2 | 1.4 |
| 3 | 1.3 | 1.4 | 1.3 | 1.6 |
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11. Effect of Nonesterified Fatty Acids
Three patient samples were spiked with 2.5, 5 and 10 mmol/L oleic acid and assayed. The data demonstrate that the AquaLite® Free F4 Assay is not significantly affected by oleic acid at the levels tested.
| Sample | Neat | 2.5 mmol/L | 5 mmol/L | 10 mmol/L |
|---|---|---|---|---|
| 1 | 0.9 | 0.9 | 1.2 | 1.0 |
| 2 | 1.5 | 1.5 | 1.4 | 1.4 |
| 3 | 1.1 | 0.9 | 1.1 | 1.1 |
12. Effect of Bilirubin
Three patient samples were spiked with 10 and 20 mg/dL bilirubin and assayed. The data demonstrate that the AquaLite® Free T Assay is not significantly affected by bilirubin at the levels tested.
| Sample | Neat | Bilirubin | |
|---|---|---|---|
| 1 | 1.1 | 10 mg/dL | 20 mg/dL |
| 1 | 1.1 | 1.3 | 1.2 |
| 2 | 1.1 | 1.0 | 1.0 |
| 3 | 1.5 | 1.4 | 1.3 |
13. Effect of Salicylate
Three patient samples were spiked with 1, 5, 10 and 25 mg/dL salicylate and assayed. The data demonstrate that the AquaLite® Free T Assay is not significantly affected by salicylate at the levels tested.
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| Salicylate | |||||
|---|---|---|---|---|---|
| Sample | Neat | 1 mg/dL | 5 mg/dL | 10 mg/dL | 25 mg/dL |
| 1 | 1.5 | 1.3 | 1.7 | 1.7 | 1.6 |
| 2 | 0.9 | 1.2 | 0.8 | 1.1 | 1.1 |
| 3 | 0.9 | 1.0 | 1.2 | 0.9 | 1.2 |
14. Effect of Phenytoin
Two patient samples were spiked with 1, 5, 10 and 25 µg/mL phenytoin and assayed. The data demonstrate that the AquaLite® Free T. Assay is not significantly affected by phenytoin at the I to 11 1100ay is needing to patients falling
Should be interpreted with courtion.
| Phenytoin | |||||
|---|---|---|---|---|---|
| Sample | Neat | 1µg/mL | 5µg/mL | 10µg/mL | 25µg/mL |
| 1 | 1.1 | 1.0 | 1.6 | 1.6 | 2.2 |
| 2 | 1.5 | 1.2 | 1.5 | 1.9 | 2.2 |
15. Effect of Phenylbutazone
Three patient samples were spiked with 1, 5 and 10 ug/mL phenylbutazone and assayed. The data demonstrate that the AquaLite® Free T. Assay is not significantly affected by phenylbutazone at the levels tested.
| Sample | Neat | 1 µg/mL | 5 µg/mL | 10 µg/mL |
|---|---|---|---|---|
| 1 | 1.0 | 1.0 | 0.9 | 0.8 |
| 2 | 1.7 | 1.6 | 1.4 | 1.7 |
| 3 | 0.9 | 0.7 | 0.8 | 0.8 |
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POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH V.
Use Universal Precautions. No known test method can offer complete Caution: assurance that products derived from human serum are pathogen-free; therefore, handle all materials of human origin as though they were potentially infectious.
Sodium azide is used as a preservative. This preservative may react with metallic plumbing to from explosive metal azides. Flush with large volumes of water when disposing of materials containing sodium azide.
As an in vitro diagnostic test, there are not direct adverse effects on the health of a patient from the use of this product. However, failure of the device to perform as indicated, the contamination of reagents, the use of reagents past the labeled expiration dates, the use of improper specimens, or human error during the performance of the test may lead to erroneous results and possible improper patient management.
VI. CONCLUSIONS DRAWN FROM STUDIES !
The data from the studies conducted demonstrate that the performance of SeaLite Sciences, Inc. AquaLite® Free T Assay is similar and substantially equivalent to that of other commercially available assays for Free T4.
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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 22 1997
Cathryn Cambria · Director, Regulatory Affairs and Quality Assurance SeaLite Sciences, Inc. 3000 Northwoods Parkway, Suite 200 Norcross, Georgia 30071
Re : K974551 AquaLite® Free T4 Assay r Requlatory Class: II Product Code: CEC December 3, 1997 Dated: Received: December 4, 1997
Dear Ms. Cambria:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as The FDA described in your 510 (k) premarket notification. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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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Page _ 1 of _1
510(k) Number (if known): K974551
Device Name: AquaLite® FT4 Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® FT4 92284
Indications for Use:
The AquaLite® FT4 Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® F14 Assay) is an in vitro diagnostic product intended for use in the quantitative measurement of FT4 in human serum in clinical laboratories. Free thyroxine measurements are used to diagnosis and treat diseases of the thyroid.
V. Michell Charles for Abe Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number 6974501
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.